Public Bill Committee

[Mr. Roger Gale in the Chair]

(Except clauses 4, 11, 14 and 23, Schedule 2, and any new Clauses or new Schedules relating to the termination of pregnancy by registered medical practitioners) - Schedule 3

Consent to use or storage of gametes, embryos or human admixed embryos etc.

Amendment proposed [this day]: No. 65, in schedule 3, page 60, line 1, leave out sub-paragraph (4) and insert—
‘(4) For sub-paragraph (2) substitute—
“(2) A consent to the storage of any gametes, any embryo or any human admixed embryo must—
(a) specify the maximum period of storage (if less than the statutory storage period),
(b) except in a case falling within paragraph (c), state what is to be done with the gametes, embryo or human admixed embryo if the person who gave the consent dies or is unable, because the person lacks capacity to do so, to vary the terms of the consent or to withdraw it, and
(c) where the consent is given by virtue of paragraph 8(2ZA) or 14(2), state what is to be done with the embryo or human admixed embryo if the person to whom the consent relates dies,
and may (in any case) specify conditions subject to which the gametes, embryo or human admixed embryo may remain in storage.
(2A) A consent to the use of a person’s human cells to bring about the creation in vitro of an embryo or human admixed embryo is to be taken unless otherwise stated to include consent to the use of the cells after the person’s death.
(2B) In relation to Scotland, the reference in sub-paragraph (2)(b) to the person lacking capacity is to be read as a reference to the person—
(a) lacking capacity within the meaning of the Age of Legal Capacity (Scotland) Act 1991, or
(b) being incapable within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000.”’.—[Dawn Primarolo.]

Question again proposed, That the amendment be made.

Roger Gale: I remind the Committee that with this we are discussing the following: Government amendments Nos. 66 to 71.
Amendment No. 32, in schedule 3, page 63, line 25, leave out ‘18’ and insert ‘16’.
Government amendments Nos. 82 and 99.
Amendment No. 9, in schedule 3, page 65, line 7, at end insert—

‘Cases where consent not required for storage and use for research
12A (1) The human cells of a person (“the donor”) may be used to bring about the creation of an embryo or a human admixed embryo in vitro; and any embryo or human admixed embryo so created may be used or stored for the purposes of any project of research without the donor’s consent if the following conditions are met.
(2) Condition A is that the human cells are lawfully taken from or provided by the donor.
(3) Condition B is that the human cells were first stored or used prior to the day on which Schedule 3 to the Human Fertilisation and Embryology Act 2008 comes into force.
(4) Condition C is that the human cells, embryos or human admixed embryos are used in circumstances such that the person carrying out the research (“the researcher”) is not in possession, and not likely to come into possession, of information from which the donor can be identified.
(5) Condition D is that it is not reasonably possible to contact the donor to obtain their consent.
(6) Condition E is that there are reasonable grounds for believing that research of comparable effectiveness cannot be carried out if the project of research for which the human cells, embryos or human admixed embryos are stored or used has to be confined to, or relate only to, material in relation to which there is an effective consent.
(7) Condition F is that it does not appear to the researcher that the donor has indicated any objection to such use or storage (as applicable).’.
Amendment No. 10, in schedule 3, page 65, line 7, at end insert—

‘Consent in relation to children for storage and use for research
12A (1) The human cells of a person (“the child”) may be used to bring about the creation of an embryo or inter-species embryo in vitro, and any embryo or inter-species embryo so created, used or stored for the purposes of any project of research without the child’s consent if the following conditions are met.
(2) Condition A is that the human cells are lawfully taken from or provided by the child before the child attains the age of 18 years.
(3) Condition B is that, at the time when the human cells are first used, the child is not competent to deal with the issue of consent in relation to either the storage or use of the human cells, embryos or inter-species embryos.
(4) Condition C is that the child does not appear to the person storing or using the human cells, embryos or inter-species embryos to have indicated any objection to such storage or use.
(5) Condition D is that a person who has parental responsibility for the child has given their consent in writing and signed it.
(6) Condition E is that there are reasonable grounds for believing that research of comparable effectiveness cannot be carried out if the project of research for which the human cells, embryos or inter-species embryos are stored or used has to be confined to, or relate only to, persons who have capacity to consent to it.
(7) Condition F is that the research is directed towards a serious medical condition from which the child suffers.
(8) In relation to Scotland, in sub-paragraph (2), for “18” substitute “16”.’.
Amendment No. 8, in schedule 3, page 65, line 7, at end add—
‘12A After paragraph 8 insert—

“Cases where consent not required for use in research to preserve fertility
9A (1) The gametes of a person (‘the child donor’) may be kept in use without the child donor’s consent if the following conditions are met.
(2) Condition A is that the gametes are lawfully taken from or provided by the child donor before the child donor attains the age of 18 years.
(3) Condition B is that, before the gametes are used, a registered medical practitioner certifies in writing that the child donor is expected to undergo medical treatment and that in the opinion of the registered medical practitioner—
(a) the treatment is likely to cause a significant impairment of the fertility of the child donor,
(b) the use of the gametes is in the best interests of the child donor, and
(c) the use of the gametes for research is necessary to preserve the fertility of the child donor.
(4) Condition C is that, at the time when the gametes are used, either—
(a) the child donor has not attained the age of 16 years and is not competent to deal with the issue of consent to the use of the gametes, or
(b) the child donor has attained that age but, although not lacking capacity to consent to the use of the gametes, is not competent to deal with the issue of consent to their use.
(5) Condition D is that the child donor has not, since becoming competent to deal with the issue of consent to the use of the gametes—
(a) given consent under this Schedule to the use of the gametes, or
(b) given written notice to the person keeping the gametes that he does not wish them to be used.
(6) In relation to Scotland, subparagraphs (1) to (5) are to be read with the following modifications—
(a) in subparagraph (2), for ‘18’ substitute ‘16’,
(b) for subparagraph (4), substitute—
‘(4) Condition C is that, at the time when the gametes are used, the child donor does not have capacity (within the meaning of section 2(4) of the Age of Legal Capacity (Scotland) Act 1991 (c. 50)) to consent to the use of the gametes.’, and
(c) in subparagraph (5), for ‘becoming competent to deal with the issue of consent to the use of the gametes’ substitute ‘acquiring such capacity’.”’.
Government amendments Nos. 100 to 102.
Amendment (a) to Government amendment No. 102, in proposed new paragraph 15G(1)(a), leave out ‘to a significant extent’.
Amendment (b) to Government amendment No. 102, in proposed new paragraph 15G(3)(b), leave out ‘have any reason to believe’ and insert ‘know’.
Amendment No. 7, in schedule 3, page 66, line 5, at end add—
‘13A After paragraph 15 (as inserted by paragraph 13 above) insert—

“Cases where consent not required for storage and research
15A The human cells of a person (‘the donor’) may be used to bring about the creation of an embryo or a human admixed embryo in vitro; and any embryo or human admixed embryo so created may be used or stored for the purposes of any project of research without the donor’s consent if the following conditions are met:
(a) Condition A is that the human cells are lawfully taken from or provided by the donor;
(b) Condition B is that the human cells were first stored or used prior to the day on which Schedule 3 to the Human Fertilisation and Embryology Act 2008 comes into force;
(c) Condition C is that the human cells, embryos or human admixed embryos are used in circumstances such that the person carrying out the research (‘the researcher’) is not in possession, and not likely to come into possession, of information from which the donor can be identified;
(d) Condition D is that it is not reasonably possible to contact the donor to obtain their consent;
(e) Condition E is that there are reasonable grounds for believing that research of comparable effectiveness cannot be carried out if the project of research for which the human cells, embryos or human admixed embryos are stored or used has to be confined to, or related only to, material in relation to which there is an effective consent; and
(f) Condition F is that it does not appear to the researcher that the donor has indicated any objection to such use or storage (as applicable).”.’.
Government amendments Nos. 103, 107 and 109 to 114.

Mark Simmonds: I do not want to rehearse points that the Minister raised this morning and go over old ground, but I have a couple of questions on the Government amendments. The first relates to Government amendment No. 65. Will she clarify whether the expectation under proposed new sub-paragraph (2)(b) of paragraph 2 of schedule 3 to the Human Fertilisation and Embryology Act 1990 is that the gametes, embryos and human admixed embryos will be retained unless consent is withdrawn? Is it a presumption of consent or a presumption of withdrawal?
My second question relates to Government amendment No. 67. Of course, I welcome parents being able to consent on behalf of their children, as we discussed earlier; otherwise, there would be a class of illnesses that was never researched in this way, as, due to the illness, adulthood would not be reached and thus consent would not be obtained. It is absolutely right that these provisions are inserted in the Bill, but what will happen if one parent consents and the other does not? What will happen if one parent disagrees strongly with the consent? Can parents or a parent ultimately withdraw consent after it has been given?
On Government amendment No. 82, I have a simple question. Under the law in Scotland, a child is considered to be under 16, whereas in England it is under the age of 18. What is the reason for that difference?
The issue to which Government amendment No. 102 relates was debated at length in the other place. I thank the Minister for tabling this very long amendment, which I understand supersedes and overrides amendment No. 7, which stands in my name. I am delighted that the Government have taken on board some of the concerns that were expressed by me and by others, but I would like to raise a couple of specific points. One is the interrelationship between proposed new paragraphs 15C(2) and 15C(6)(a), which limits research on the original debilitating disease. What will happen if the individual has another disease that is proven to be scientifically linked to the original disease? That may come about as a result of scientific advances. Will we have to return and alter primary legislation or can the change be made in regulations? Is there a need to alter the Bill?
The other provision in the Government amendment that I am very concerned about is proposed new paragraph 15D(3), whereby if a researcher cannot find a carer who is willing to be consulted on the use of an adult who is unable to give consent in respect of cells, the researcher can nominate someone to act on their behalf, who may not know the adult lacking the ability to consent and may not have that adult’s interests at heart. I am not sure that there are enough safeguards to ensure that such people, who will not necessarily be related to the person who cannot give consent, have the necessary ability and have in mind the interests of the potential patient and person who cannot grant consent. It is very important that sufficient safeguards are in place to ensure that that is the case.

Evan Harris: As we have heard, this is an extensive group of amendments, and I have a number of questions in addition to those that have been asked. I shall try to go through them in the order of the amendments, but I hope that you, Mr. Gale, the Minister and the rest of the Committee will bear with me if my comments end up jumping about.
First, on Government amendment No. 65, I do not necessarily follow how proposed new sub-paragraph (2A) links to proposed new sub-paragraph (2)(c). Proposed new sub-paragraph (2A) states:
“A consent to the use of a person’s human cells to bring about the creation in vitro of an embryo or human admixed embryo is to be taken unless otherwise stated to include consent to the use of the cells after the person’s death.”
That seems fair enough, but proposed new sub-paragraph (2)(c) states that
“where the consent is given by virtue of paragraph 8(2ZA) or 14(2)”
it must
“state what is to be done with the embryo or human admixed embryo if the person to whom the consent relates dies”.
Proposed new sub-paragraph (2)(c) adds that the consent
“may (in any case) specify conditions subject to which the gametes, embryo or human admixed embryo may remain in storage.”
The position on proposed new sub-paragraph (2)(b) is straightforward because the person who gives consent and who then dies is the person from whom the embryos are taken, but the question is how the provisions relate to the death of the person who gives consent for that person. My hon. Friend the Member for Southport raised that question independently in a message to me, and I hope that I have done his question justice while raising my own. I hope, too, that the Minister will forgive me if she feels that she has already clarified how the provisions will work, but I did not spot her explanation, so it would be helpful if she clarified the point.
Amendment No. 67 is quite complex. Again, I would be grateful if the Minister clarified what effect the insertion of proposed new sub-paragraphs (3ZA), (3ZB) and (3ZC) will have. Those provisions are mirrored in other amendments, but it is not entirely clear—even reading the amendment in the context of the Bill and the Act as amended—exactly what their effect will be.
My next question relates to some of the Minister’s other amendments. The schedule raises another issue, but it is a matter for the schedule stand part debate, so it will be easier if I return to it then.
I turn now to the substantive Government amendments. It is appropriate at this point to speak to amendments (a) and (b)—

Roger Gale: Order. The hon. Gentleman assumes that there will be a schedule stand part debate. I have yet to decide that, but the way things are going, the debate is becoming very comprehensive indeed.

Evan Harris: The case that I want to put in that respect is that there are extensive matters in schedule 3, which is lengthy, that are not subject to the amendments. I can try to bring those matters into my remarks, but—

Roger Gale: Order. The hon. Gentleman is right that there are matters in the schedule that are not covered by the amendments, but it is wrong to assume at this stage that there will necessarily be a stand part debate.

Evan Harris: I want to express not an assumption, but a hope. Otherwise, it will be difficult for me to put my points on this extensive schedule because they are totally unrelated to the amendments. I will bow to your discretion at the appropriate time, Mr. Gale.
I am very grateful to the Government for tabling amendment No. 102 and other related amendments. As the Minister will know, several scientific organisations expressed concern when it appeared that the Bill would not permit the use of existing cells. She will be aware of the letter to The Times that was signed by a number of Nobel laureates, headed by Sir Martin Evans, Sir Paul Nurse and Sir John Sulston. It was supported by Sir Ian Wilmut, director of the Medical Research Council centre for regenerative medicine; Sir Richard Sykes, a trustee of the UK Stem Cell Foundation; Lord May of Oxford, a former chief scientific adviser to the Government; Professor Bobrow; Dr. Robin Lovell-Badge; and a number of other leading researchers, all of whom expressed concern.
The current situation is a tribute to the Government’s general handling of the issue since consultation began several years ago. We are now in a position to welcome the fact that they looked into the issue that was raised, consulted the scientific community and came up with an amendment that seems to answer almost all its concerns. I recognise what a job of drafting that was, given the length of the amendments. I know that the Government’s default position might not be to spend a huge amount of time on drafting, so that shows that they recognised that the issue is important.
The same applies to the provision on children. It was not clear that it would be permitted, and the Government expressed the importance of obtaining explicit and specific consent when embryos were created, because of concerns about people’s autonomy. I understand that, as do the members of the research community whom I have spoken to—if I may speak for them—and patients groups. It is particularly pleasing for the Genetic Interest Group, which worked extremely hard on the issue and wrote a letter to Professor Lord Darzi on 25 January, expressing support for the amendment tabled in the other place and standing in the name of Lord Patel.
It is welcome that the Government have not only addressed that issue, but taken the time and made the effort to ensure that the same issues should apply in questions of adults without capacity.
I have tabled two small probing amendments to Government amendment No. 102. Amendment (a) questions the threshold for research to be permitted, which is set out in proposed new paragraph 15G in amendment No. 102. Paragraph 15G(1) states:
“A licence may not authorise the application of paragraph 15F”—
which is to allow the use of existing cell lines—
“unless the Authority is satisfied—
(a) that there are reasonable grounds for believing that scientific research will be adversely affected to a significant extent if the only human cells that can be used to bring about the creation in vitro of embryos or human admixed embryos for use for the purposes of the project of research are”
those in respect of which there is an effective consent.
My concern is with the phrase “to a significant extent”, for two reasons. First, that is a different measure from the one used in relation to consent for the use of children’s cells, earlier in the amendment. For example, condition D in proposed new paragraph 15A(5) is expressed in terms of
“reasonable grounds for believing that research of comparable effectiveness cannot be carried out”.
That seems to me to be a very appropriate test. There is a reasonableness test, which is important and which guides the licensing committee or the HFEA in deciding whether they are prepared to license the use of the cells. Also, its reference to comparable effectiveness focuses the question on the outcome of the research, not the convenience of researchers.
I totally accept the Minister’s statement that she would not want a test that merely enabled existing cell lines to be used simply for convenience and because the scientific research might be thought to be “adversely affected”. I understand her concern about leaving it at that; it would clearly adversely affect researchers to have to get consent when they could simply buy in cell lines.
I hope that the Minister accepts that I accept that my amendment on its own is not adequate, but I urge her to consider whether she might use wording such as “comparable effectiveness”, which focuses on outcomes. If that is not done, it will be hard for the HFEA to interpret “significant extent”, whereas
“reasonable grounds for believing that research of comparable effectiveness cannot be carried out”
is much clearer. It will be hard for scientists to know what the HFEA will decide counts as “significant extent”.
I hope that the Minister recognises that there are two ways of doing this and that there may be a slightly better way than the one she has proposed.
Amendment (b) would amend condition B in proposed new paragraph 15G(3). There is a problem, in that conditions B and C might not capture a frequent occurrence. A researcher might have reason to believe that P has died because the cell lines were taken 10 years ago from someone with cancer, but might not know that P had died, in which case condition C would not apply.
There are three possible situations. The first is that the patient has died, in which case condition C would apply, so that is straightforward. Another is that the researcher has no decent reason to believe that the person has died, such as when the cell lines are taken from the biopsy of a healthy person, an umbilical cord or whatever. A third scenario is that the researcher has reason to believe that the person is dead, but does not know. I understand fully the Minister’s point that researchers must take reasonable steps to ensure that they can identify a relative if the person has died. It would not be good enough for the researcher to take the view, “I don’t know if the person’s died, so I’m going to treat them as simply uncontactable, not worry about contacting a relative and press on.” I accept that she made a valid point.
The first aspect of condition B specifies that the researcher must have
“taken all reasonable steps to contact the person”.
It could be possible to resolve the problem that I have identified by adding a further provision that the researcher must also have taken reasonable steps to establish whether the person has died. If they had done both those things, it would be reasonable for the researcher, even if they had a reason to believe that the person may have died, to treat the person as uncontactable, not necessarily dead. I hope that the Minister will accept that that is a concern in the research community, and I hope that she will deal with it in her response, if not now.
I want to draw the Committee’s attention to a couple of other aspects of the amendments. One of them specifies the condition that the person must be likely to regain capacity, but I want to probe whether that is the appropriate test. There may be a situation—I am talking about an adult, not a child who is likely to gain the capacity to consent at some point—in which someone has a clinical condition that makes it possible that they might regain capacity, but difficult to argue that it is likely that they will. I do not want to spend the Committee’s time identifying specific cases, but it would be useful if the Minister considered whether there would be a better test that would enable the provision not to be quite so tight.
I turn to amendment No. 8, which I tabled. Unlike amendments Nos. 9 and 10, its purpose is not dealt with by the Government amendments. Under the Bill as it stands, it will be possible to store the gametes of children who are about to undergo chemotherapy or some other medical research that threatens their future fertility. Under the quite reasonable provision in paragraph 12 of schedule 3, the tissue could be stored without the explicit specific consent of the person on the basis of that person’s best interests.
That all makes sense. The problem is, however, that for this to be effective, it is important that the storage techniques are correct. The basis of new paragraph 9 is that the gametes are lawfully taken and that their storage is in the best interests of the child. It is hard to meet that test—or certainly more difficult—if the storage procedure that is used fails to meet the requirements of that test. Let us take the example of a biopsy of testicular tissue taken from a child without the capacity to consent, such as a prepubertal boy. If that storage is not done correctly, the procedure is not going to work, even if the clear intention is to provide something that will help the child retain his fertility and thus meet the best interests of that child.
As I understand it, freezing such gonadal tissue is a tricky business. Amendment No. 8 would provide grounds whereby it would be possible—again, under the same best-interest tests—to use part of the tissue that had been taken, frozen and stored to test whether the freezing technique successfully met the purpose for which the tissue was taken: preserving fertility.
I think the Minister understood that that was the intention of the amendment. She made the very fair point that this really ought to be a last resort and that when there was a decent alternative, one would not need to do this. She said that the alternative would be to wait for the child to gain capacity, when he could consent to the use of stored gametes to test the freezing. The problem is that we might be in a position in which it would take some years for that situation to arise.
For example, if the tissue that was frozen was taken from a six-year-old boy with the hope of preserving fertility and, at the age of 14, the child acquired capacity—essentially, competence to consent to research being done, including testing, albeit only for the purpose of research, the fertilisation ability of the sperm, which would not be allowed at present—one could test whether the storage of the six-year-old’s sperm was being carried out correctly. That, however, would be some way done the line, and if it turned out that the storage was done incorrectly, nothing could be done to help either that person—whose tissue had been taken but was not going to be useful—or any other child whose gametes were stored and frozen under the same procedures in the intervening eight years.
There might be a small gap in which some provision is needed to allow this to take place. If, under Government amendment No. 102, it is legitimate, in the best interests of the child, for a child’s cells to be used to create an embryo for research into a disease from which the child and other people are suffering, is there a significant difference between that and using another cell—a gamete cell—to create an embryo by fertilisation for research under the 14-day rule, also in the best interests of that child, even though one could probably do it eventually in a number of years time when the child gained capacity? I would be grateful if the Minister would consider that question.
I have a number of other related points that are specific problems with the schedule. They are not substantial issues, but I would like to save them for a stand part debate, as I have focused all my remarks on this group of amendments. However, if it is your understanding that there will not be a stand part debate, Mr. Gale, I will try and deal with them in the next group.

Roger Gale: Let me clarify the position. If I have caused the confusion, I will resolve it. There are issues contained in schedule 3 that are not covered by amendments. If any hon. Member wishes to raise those issues, they may of course do so. What we cannot do is find ourselves in a situation in which we have thoroughly debated acres of text that we will then debate again during a stand part debate. The hon. Gentleman referred to specific amendments and said that he wanted to discuss them later. I think that that is what he said, but if I misunderstood him, I freely apologise. By the time that we get to the stand part debate, we cannot go back over ground that we have already covered. I think we all understand that.

Brian Iddon: I wish to seek a small assurance from the Minister regarding the Government amendment No. 102, which is complicated. Proposed new paragraph 15D(2) will require a researcher to
“take reasonable steps to identify a person who”
is caring for P
“otherwise than in a professional capacity or for remuneration”.
I am particularly concerned about the phrase “or for remuneration”, because a very close person could be caring for P who was receiving remuneration from a number of sources. For example, the remuneration could be compensation for an accident. I am particularly concerned about what would happen if the carer of P was receiving benefits. Would that regarded under this amendment as remuneration?

Tom Clarke: I shall try, Mr. Gale—as we all will—to stick to your guidelines and be specific, but some of the points that I want to raise follow from the point made that my hon. Friend the Member for Bolton, South-East, as well as some of the points raised by the hon. Members for Boston and Skegness and for Oxford, West and Abingdon, although perhaps I will make them from a different perspective.
May I begin by posing the question that the hon. Member for Boston and Skegness asked about Scotland? I am a little confused about that one, and I cannot quite understand why, with some of the issues that we are now addressing, we start at 16 in Scotland. Perhaps the Minister will clarify that.
On Government amendment No. 65, may I concentrate for just a moment on proposed sub-paragraph (2)(a)? I am slightly puzzled by the Minister’s use of the word “storage”. It seems to me that this particular provision reaches well beyond that. It is assumed that, after we die, the cells can be used for various purposes unless we state otherwise. This seems to me to be presumed consent. For the sake of posterity and those who read Hansard closely, may I say for the record that I would not wish my cells to be used for such research after I am gone? It is wrong for all of us to assume that our constituents take the same view on the matter. I would be interested to hear, for example, how the British Medical Association has advised the Minister on this issue?
I thought that the rules on consent in the Bill—I recognise that consent is the essence of what we are discussing—were very tight and that they formed one part of the Bill that was pretty secure. However, Government amendment No. 102 seems to widen things considerably—frankly, beyond what I had anticipated. To go from the tight, robust provisions in the original Bill to around 260 lines on
“Cases where human cells etc. can be used without the consent of person providing them”
seems to me to be changing the ball game somewhat.
Again, to draw on something specific, proposed new paragraph 15D in amendment No. 102 refers to how R—the researcher—can nominate someone who only has to fill the criteria of having
“no connection with the project”.
That is a massive loophole. Conceivably, a researcher could appoint a different researcher on a different project to speak as an advocate for the person who has died. If that is not the case, I would welcome clarification from my right hon. Friend. If that is the case, we all know what the consultation will lead to.
As the Minister knows, I am committed to advocacy, as I was at the time that I was fortunate enough to steer a Bill on disabled persons through the House. Advocacy is of the utmost importance when we consider all Government Bills. However, it is essential to remember that the advocate is not speaking for himself or herself, but for the person. It is not for the advocate to express a view, which might not necessarily be that of the person, and I would like my right hon. Friend to underline that point.
Let me put a specific question in that context. Does the Minister recognise that there seems to be a clear conflict of interest in having the licence holder for the research project nominating the person under proposed new paragraph 15D(3) who is to be consulted on behalf of the person lacking capacity? There is no indication that the person to be consulted on behalf of the person lacking capacity has even to see the person lacking capacity. A lot of clarification is called for.
Before I conclude, I remind Labour Members about the letter dated 25 March that we all received from the Prime Minister. He wrote:
“we will have a free vote on the three new ethical issues on which the house has not previously taken a view”
If the Government amendments are accepted, which I anticipate will happen, we will have a new profound ethical issue to discuss. I hope that the provisions will receive close scrutiny on Report and that my right hon. Friend the Minister will agree that they, too, would thus be the subject of a free vote.

Dawn Primarolo: I will try to deal with the questions asked during our debate on consent. I start by responding to the general points made by my right hon. Friend the Member for Coatbridge, Chryston and Bellshill and my hon. Friend the Member for Bolton, South-East about the appointment of a representative when a carer is not available. I remind them that the 1990 Act has requirements on effective consent and what that constitutes. Effective consent is required on the use of embryos, and the Bill seeks to put in place the same. That will cover what the embryo can be used for, the maximum periods of storage for gametes or embryos, what should be done with the embryo or gamete after death, and any other conditions that are wished to be placed on embryo use. That picks up the point that my right hon. Friend the Member for Coatbridge, Chryston and Bellshill made about consent. While there can be general consent—we can agree to the use of our embryos or gametes for all research—we can also specify, if we choose.
To take my right hon. Friend’s example, he might agree to research on particular areas that might be connected with a condition he does not have, but go on to say that he wishes to withhold consent for other areas of research. That can be done, and it is done under the aegis of effective consent in the 1990 Act. With regard to the operation of that consent, the Bill seeks to make sure that for human gametes used to create a human admixed embryo, the use of the embryo and its storage are brought into the same regulations and given the same protection.
The Government amendments deal with the exceptions we are discussing with regard to how consent works and being able to specify the consent, which has to be given. That includes, for instance, counselling and discussions. In this hierarchy, in the particular circumstances mentioned by my right hon. Friend the Member for Coatbridge, Chryston and Bellshill and my hon. Friend the Member for Bolton, South-East—in circumstances in which an individual is incapable of giving consent—the carer is the correct person to go to. The question is if there is not a carer, what happens?
The process in that case follows the provisions of the Mental Capacity Act 2005. This picks up the point made by my right hon. Friend the Member for Coatbridge, Chryston and Bellshill about what he described as an advocate, which may be somebody who is charged with a responsibility under that Act. He also made the specific point that the views expressed have to be those of the individual who they are representing. Clearly, those provisions need to be spelled out in discussion about the safeguards and how they operate between the relevant authorities—in this case the Ministry of Justice and the HFEA—to make sure that is absolutely the case. There is an absolute protection there.
That also covers the point that my hon. Friend the Member for Bolton, South-East made with regard to remunerations. A carer could be in receipt of a payment such as independent living allowance, but that must not interfere with the rights and protections clearly conveyed in the 2005 Act. That is where we are locating ourselves to ensure that we follow through with the same rights that the House has already identified as being necessary in cases where the individual does not have the capacity to provide consent. I hope that that clarifies those points.
Moving on to the points made by the hon. Member for Boston and Skegness about how Scottish law differs—which, as this is a devolved matter, it does quite a lot—I do not feel sufficiently competent to give him a specific answer. I wonder whether he will allow me to get the Scottish Law Officers to give us a proper answer as to how the laws interact, particularly, as he mentioned, around the age of 18.

Mark Simmonds: Of course, I will be more than content with the Minister’s promise to get more detailed advice. However, my understanding of the Bill is that there are parts of it that cover Scotland, so the power is not devolved. It is relevant for the Committee to understand why there are differences between Scotland and England.

Dawn Primarolo: I absolutely agree with the hon. Gentleman. May I refer to my experience as a Treasury Minister? The Finance Bill makes legislation for the whole UK, but, nevertheless, at times it has to interact with Scottish law as it has evolved. This is such a case. I will be happy to get that information for the hon. Gentleman so that he is satisfied that there are not any difficulties here.
The hon. Gentleman asked questions about consent, the child, and the interaction of parents. I think he is looking for where the crossover is between the parents and the child’s point of competence. The consent would endure unless it were withdrawn or varied by the parents—I shall come on to the point about what happens when both parents do not agree—or when the child became competent to consent themselves. I do not know whether the hon. Gentleman wanted to know whether it was set for all time or could not be varied, but it can be, under the restrictions that are set out by the Bill.
Parents can withdraw consent, or vary it, but that would be subject to the limits that apply to all effective consents under paragraph (4), given how far the research might have progressed. That is one of the issues, because there might have been a great deal of work and expenditure. We must not talk about destroying all that, and that is a general caveat—can one talk about a general caveat?—and, more, a general requirement within the provisions.
If there were a dispute between the parents, they might have to go to the courts to resolve the matter because that does not fall under the Bill. Parents’ responsibilities and their joint responsibilities are a difficult area, and it would be difficult to legislate on a dispute in a partnership where further use may be disputed. I am afraid that there is no other way, in such limited and regrettable circumstances, that such a matter can be resolved.

Mark Simmonds: I am grateful for the clarity that the Minister is putting on this area. Does that mean that the consent of one parent is sufficient in this particular case?

Dawn Primarolo: I think that the consent of one parent without the other parent dissenting would be considered to be the consent of the parents, so yes, technically, one parent could be deemed to be speaking on behalf of both. The obligation would be to ensure that the other parent would have to say to the contrary. I think that that is how the law would operate under such circumstances.
The hon. Gentleman asked about whether the provision limits research to the original debilitating disease, or whether it could be extended to linked disorders. If the research into the condition was linked to the original condition, it would be permitted. Research could be into the condition suffered or a similar one. Clearly, any provision in that area must be about either a disease or disability that the child has, or its treatment and care.
The hon. Gentleman raised the point about someone who might be unable to find a carer and what the appointment of the other person means. I have answered, clearly I hope, that that falls within the confines of the Mental Capacity Act 2005 and the guidelines there. The same answer goes to my right hon. Friend the Member for Coatbridge, Chryston and Bellshill and my hon. Friend the Member for Bolton, South-East. I have answered the Scotland point.
A point was raised about whether a researcher can nominate another researcher—my right hon. Friend the Member for Coatbridge, Chryston and Bellshill touched on that. The answer is no, as it will be governed. It will have to be an appropriate person as set out in the Mental Capacity Act, acting and speaking on behalf of the patient—the individual considered not to have capacity, as my right hon. Friend said. This is a delicate area and it is clearly dealt with in that Act.
I think that I have dealt with the issues raised by the hon. Member for Boston and Skegness, so I will attempt to answer the questions asked by the hon. Member for Oxford, West and Abingdon. If I do not deal with them all, it is because I did not necessarily understand them, so forgive me. However, I will try.
I understand the point that the hon. Gentleman again made about the issue of “significant extent”. As I said in my opening remarks, together with all the consultation and advice that we have had, the Government are trying to weigh the scientific burden of being unable to use existing cells against the rights of the person who donated those cells. I am not convinced by the hon. Gentleman’s alternative wording—he accepts the principle, but is not keen on the word “significant”. I do not think that the wording he suggests is a high enough hurdle for researchers. It is important that “significant extent” is the appropriate test to comply with and it should not be lowered. The heart of his argument seems to be that it is too high, but we have set it there because we think it should be high.

Evan Harris: I accept what the Minister says and that simply taking out those words is not satisfactory. I suggested that she might consider using the same wording about the research not being of comparable effectiveness, which she has deemed satisfactory. I agree with her about the other provisions that relate to patients without capacity and children who do not yet have capacity, where there is a different threshold. My concern is not that “significant extent” makes the threshold too high, but rather that it is not easy to interpret. I am at one with her on where she wants to be, but I wonder whether she will consider the alternative wording.
Briefly, I received a message from the Medical Research Council and the Wellcome Trust saying that they support the thrust behind amendment (a) to Government amendment No. 102. Unfortunately, I do not have that in writing, so I accept that at the moment it is hearsay, although it might give the Minister pause to consider the matter, or at least to agree to think about it a little more.

Dawn Primarolo: I am absolutely prepared to accept the hon. Gentleman’s word about who supports the amendment and, of course, I always take note of those illustrious bodies. However, here the difference is clear as to why we are not using exactly the same wording. The wording that is used elsewhere refers to cases that involve consent from others. We want to connect that with cases with no consent and have included a worthy higher test for that reason.
I accept the hon. Gentleman’s argument, and I am always happy to reflect on any view held by members of the Committee, but this is an important principle and I am not convinced that other words could be used or that we should lower the test.
The hon. Gentleman asked questions to clarify the effect of interactions between sub-paragraphs (3ZA), (3ZB) and (3ZC). Sub-paragraphs (3ZA) and (3ZB) clarify the fact that, in the limited circumstances referred to later in the schedule, the consent of a parent will be treated as effective consent of the child. That means that all the provisions of schedule 3 that are attached to effective consent apply to the parent. For example, the parent is given the opportunity for counselling and they can vary or withdraw the consent, which is what I said in my opening remarks.
Sub-paragraph (3ZC) clarifies the fact that if a child becomes competent to consent, their parents’ consent is treated as if it were their own, which enables the child—now competent, which is the point made by the hon. Member for Boston and Skegness—to choose with consent at the appropriate time whether they consider it necessary to vary matters. That will ensure that the embryos are not automatically destroyed if the child does not want that to happen.
The hon. Gentleman asked about the interaction starting with parents and crossing over into a competent child or adult, and the issues of storage. He also asked about the intentions of proposed new sub-paragraph (2)(c) in amendment No. 65. The intention is that the parent, at the outset, will specify what should happen to the embryo created using the child’s cells if the child dies and if the parent died later. The consent would have already been given, so further provision is not needed is such a case.
I come to amendment (b), tabled by the hon. Member for Oxford, West and Abingdon to Government amendment No. 102. I took advantage of the break between the morning and afternoon sittings to discuss matters further. I am sure that he appreciates that the Government want to ensure the protection of the rights of the deceased person’s relatives in cases where their relatives have been identified and the researcher wishes to use the tissue. However, I understand that there may be an important point that he is making about when relatives cannot be traced and whether there should be some qualification on whether relative consent is required.
I do not want to make a hasty decision on the basis of today’s discussion. I am sure that members of the Committee appreciate that we are discussing a complex set of exceptions that try to take into account all human rights. However, I want to reflect on our views on the provision, along with what the hon. Gentleman said about it, to see whether a slight problem needs to be tidied up. I shall, of course, keep all members of the Committee informed of the outcome in relation to our decision. I hope, therefore, that he will not press the amendment to a Division, but will give us time to consider the matter.
My last point goes back to that made by my right hon. Friend the Member for Coatbridge, Chryston and Bellshill about nominating somebody if there is not a carer to represent a person who is without capacity. This incredibly important and I bow to his extensive knowledge and experience in this area. It is crucial that we get this right. We would expect and require the HFEA to be satisfied that the appointment was done correctly, that they were representing the individual concerned and that the researcher had undertaken all the checks possible before reaching that stage of appointment. I say to my right hon. Friend that that makes the exceptions very tight indeed and ensures that the concerns that he and the rest of us rightly hold have been properly dealt with.
I think that I have answered all the questions to the best of my ability, and if I find that I have missed anything when I check the record, I will be more than happy to write to members of the Committee.

Evan Harris: I confirm that, as far as I am concerned, the Minister has addressed all the points that I raised on the amendments and I have no further comments to make on them. I apologise if I mis-spoke or confused the situation earlier in respect of issues relating to the schedule.
I would also like to thank the Minister for considering amendment (b) to Government amendment No. 102, and I repeat that I do not intend to press either that amendment or amendment (a) to Government amendment No. 102. I look forward to hearing the Minister’s reflections.
On amendment (a), the Minister has confirmed that the test is a higher one. It is helpful that that is understood, unless one is a researcher who now feels that he will be disadvantaged, so there are mixed blessings to these Committee debates.
The Minister says the test is a higher one because, in the case of the child who does not yet have capacity or the patient without capacity, there is a substitute consent involved, whereas here there is not such a substitute consent. That is the first time that that has been explained, and I will, if I may, reflect on whether it is therefore a rebuttal of the argument that the tests should be the same. I hope, however, that I can reflect on whether there is an alternative wording that would retain a higher test but was not as open to interpretation—and possibly misinterpretation—or as difficult to interpret as the current wording. However, I am grateful to the Minister for her responses to the points that I raised.

Mark Simmonds: I join the hon. Gentleman in thanking the Minister for her extremely comprehensive responses, both to my amendments and to the questions I subsequently asked. In that context, I am happy not to press my amendments, which have been superseded by the Government amendments.
I thank the Minister again for tabling those amendments, and I look forward to her clarification of the disparity between Scotland and England. It might be helpful if she circulated that letter to every member of the Committee. I hope she stipulates which parts of the Bill apply to the whole United Kingdom and which only to England and Wales. There are some differences in the Bill, and there is certainly some confusion among those who are concerned with it—not just in Committee, but outside—as to which parts are relevant to which parts of the United Kingdom.

Amendment agreed to.

Mark Simmonds: I beg to move amendment No. 30, in schedule 3, page 61, line 32, leave out ‘12’ and insert ‘36’.

Roger Gale: With this it will be convenient to discuss amendment No. 31, in schedule 3, page 61, leave out lines 35 to 39.

Mark Simmonds: We have spent a long time discussing schedule 3, so I will be brief. The amendments are probing and relate to the storage time of the embryos. Under the Bill, storage of the embryos is legal for 12 months. I welcome the Government’s introduction of a cooling-off period, when one person seeking treatment or the gamete donor withdraws consent. Why only 12 months? If there has been a disagreement between two people applying for treatment, lawyers occasionally become involved in an attempt to dispute the decision and it could take much longer than 12 months for the process to be resolved. A longer cooling-off period before an embryo is destroyed may well be necessary—at least the option of an extension to the cooling-off period.
Amendment No. 31, which is probing, expresses concern about the cooling-off period. The explanatory notes say that the cooling-off period allows the embryos to remain lawfully stored while a resolution is reached, but proposed new section 4A(4)(b) in paragraph 7 of schedule 3 allows the embryo to be destroyed before 12 months have elapsed if both parties consent. That appears to be a slight contradiction.
The time is a difficult one for both partners, and decisions could be taken that are subsequently regretted. Removing the provision and instead having a mandatory cooling-off period of 12 months would give both parties an opportunity to reconsider their initial decision.

Evan Harris: I note the interesting points made by the hon. Gentleman, although I do not want to comment directly on their merits or otherwise. I want the Minister to confirm whether it is her view, as it is mine, that the courts made the right decision in the case of Natalie Evans. It was difficult for the lady concerned, and there was a great head of steam built up about whether it was right that she was denied the right to use the stored gametes or embryos when the consent had been withdrawn.
My view is that in 1990 Parliament was clear about its intention in such a case, and I would be grateful if the Minister confirmed that the Bill does not change that provision. Despite everyone’s sympathy for people in the position of Natalie Evans, the decisions of the courts in that case were right as far as Parliament had intended.

Dawn Primarolo: I can confirm that. At all stages, the principle of importance in the last question is that the consent of both gamete donors has to be there. That is what the courts upheld, which is absolutely right. It has not changed. The Bill does not propose to move away from the principle of consent of both parties in such cases. However, we are trying to recognise the fact that, if one party withdraws consent to storage and use, it is only fair that the other should be informed. When that withdrawal of consent occurs, the Bill places a duty on the clinics to inform the second gamete provider.
The clinics also have a duty to keep the embryos safely stored for one year, until agreement has been reached by both parties with an interest in the embryo. That comes on to the point that I will deal with in a minute—the hon. Gentleman’s second amendment—which is that if both parties say “destroy”, the consent is withdrawn and that happens. That is what it means and that is what the principle is. That is the principle that has been upheld by the court.
The Bill introduces a one-year cooling-off period for the storage, which will be activated immediately in the case of one party withdrawing consent if written notification is received by the clinic storing the embryo that one of the gamete providers is withdrawing consent to continued storage and use.
The cooling-off period will ensure that the embryo remains legally stored for a maximum of 12 months to allow the other gamete provider to be informed of the decision and to allow time for reflection on that decision, with the possibility that both parties might reach a private agreement on the future of the embryo. Clearly, that would be a better solution than ending up in the courts, which we have discussed in relation to other examples. The question is how far any statute should reach into the private relationship between two individuals.
The 12-month period recognises the distress that such a situation can cause to the couples involved, but ensures that the process of reaching a conclusion is not allowed to drift and that clinics can deal with storage. The provision also deals with the fact that the individuals concerned have to recognise the importance of both individuals’ consent and recognises the fact that both can withdraw that consent. I understand the point of amendment No. 30: why should the period not be longer? Yet if the situation cannot be resolved in 12 months, why would we expect it to be resolved in a longer period? These are important and direct issues that should not be left for long before resolution.
On amendment No. 31, where both parties have consented to the destruction of the embryo, that would run completely counter to the whole point of consent, which is about the individual’s responsibilities in coming to those decisions. They cannot be transferred or given a cooling-off period. They are the responsibilities of those two individuals, and once both have said in writing that consent is withdrawn, that is it. That is the right way to proceed.
I understand the desire of the hon. Member for Boston and Skegness to probe this area, which is difficult, but the Government have moved as far as is reasonable, given that in the end—particularly given the circumstances of such treatment—the two individuals have to continue to consent. In distressing circumstances, when one person withdraws consent for a short period, there is at least the opportunity to inform the other donor and for final decisions to be taken. I therefore ask the hon. Gentleman not to press his amendment.

Mark Simmonds: I thank the Minister for her response. Of course, I agree that consent of both gamete donors is essential and it is right that one of the consenters is informed if the other withdraws consent. It is also right that speed is of the essence in resolving these matters. The point I was trying to elucidate with amendment No. 30 is that a dispute, potentially involving lawyers, could last longer than 12 months, and there does not seem to be any option to extend that period. As I understand the Bill, even if such a dispute were still going on at the 12-month cut-off, the embryo or gamete would ultimately be destroyed.

Dawn Primarolo: But that happens now. Where there is legal dispute over the requirement to defer the decision, I do not think that that has changed. We are talking about a new, specific cooling-off period that was not present in that circumstance.

Mark Simmonds: I am aware of that, but I do not think it addresses the point that a dispute may be going on that could be resolved one way or the other and which, obviously, becomes hypothetical once the embryo has been destroyed. Nevertheless, I think the discussion has been useful.

Dawn Primarolo: Perhaps I was not clear enough. Where there is a legal dispute and the courts are involved, the HFEA can defer a decision. I have referred to that before with regard to one of the cases we talked about. That position has not changed. This is not about where there is an interaction with the courts, so it is not an absolute. This is where there is not, and we are hoping that two individuals will simply sort it out themselves.

Mark Simmonds: That is an extremely helpful intervention, if I may say so. On that basis, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Amendments made: No. 66, in schedule 3, page 62, line 12, after ‘(b)’ insert ‘, (ba)’.
No. 67, in schedule 3, page 62, line 15, at end insert—
‘(3ZA) If the Authority is satisfied that the parental consent conditions in paragraph 15A are met in relation to the proposed use under a licence of the human cells of a person who has not attained the age of 18 years (“C”), the Authority may in the licence authorise the application of sub-paragraph (3ZB) in relation to C.
(3ZB) Where the licence authorises the application of this sub-paragraph, the effective consent of a person having parental responsibility for C—
(a) to the use of C’s human cells to bring about the creation of an embryo in vitro for use for the purposes of a project of research, or
(b) to the use for those purposes of an embryo in relation to which C is a relevant person by reason only of the use of C’s human cells,
is to be treated for the purposes of sub-paragraphs (1) to (3) as the effective consent of C.
(3ZC) If C attains the age of 18 years or the condition in paragraph 15A(3) ceases to be met in relation to C, paragraph 4 has effect in relation to C as if any effective consent previously given under sub-paragraphs (1) to (3) by a person having parental responsibility for C had been given by C but, subject to that, sub-paragraph (3ZB) ceases to apply in relation to C.
(3ZD) Sub-paragraphs (1) to (3) have effect subject to paragraphs 15B and 15F.’.
No. 68, in schedule 3, page 62, line 16, leave out ‘and (3)’ and insert ‘, (3) and (3ZB)’.
No. 69, in schedule 3, page 63, line 1, at end insert—
‘(2ZA) Where a licence authorises the application of paragraph 6(3ZB) in relation to a person who has not attained the age of 18 years (“C”), the effective consent of a person having parental responsibility for C to the storage of an embryo in relation to which C is a relevant person by reason only of the use of C’s human cells is to be treated for the purposes of sub-paragraph (2) as the effective consent of C.
(2ZB) If C attains the age of 18 years or the condition in paragraph 15A(3) ceases to be met in relation to C, paragraph 4 has effect in relation to C as if any effective consent previously given under sub-paragraph (2) by a person having parental responsibility for C had been given by C but, subject to that, sub-paragraph (2ZA) ceases to apply in relation to C.’.
No. 70, in schedule 3, page 63, line 2, for ‘sub-paragraph (2)’ substitute ‘sub-paragraphs (2) and (2ZA)’.
No. 71, in schedule 3, page 63, line 17, leave out ‘paragraph 4A(4)’ and insert
‘paragraphs 4A(4), 15B and 15F’.
No. 72, in schedule 3, page 63, line 20, leave out ‘(“the child donor”)’ and insert ‘(“C”)’.
No. 73, in schedule 3, page 63, line 21, leave out ‘the child donor’s’ and insert ‘C’s’.
No. 74, in schedule 3, page 63, line 24, leave out
‘the child donor before the child donor’
and insert ‘C before C’.
No. 75, in schedule 3, page 63, line 27, leave out ‘the child donor’ and insert ‘C’.
No. 76, in schedule 3, page 63, line 31, leave out
‘the fertility of the child donor’
and insert ‘C’s fertility’.
No. 77, in schedule 3, page 63, line 32, leave out
‘the best interests of the child donor’
and insert ‘C’s best interests’.
No. 78, in schedule 3, page 63, line 36, leave out ‘the child donor’ and insert ‘C’.
No. 79, in schedule 3, page 63, line 39, leave out ‘the child donor’ and insert ‘C’.
No. 80, in schedule 3, page 63, line 43, leave out ‘the child donor’ and insert ‘C’.
No. 81, in schedule 3, page 64, line 4, leave out ‘he’ and insert ‘C’.
No. 82, in schedule 3, page 64, leave out line 7.
No. 83, in schedule 3, page 64, line 10, leave out ‘the child donor’ and insert ‘C’.
No. 84, in schedule 3, page 64, line 17, leave out ‘(“the patient”)’ and insert ‘(“P”)’.
No. 85, in schedule 3, page 64, line 18, leave out ‘the patient’s’ and insert ‘P’s’.
No. 86, in schedule 3, page 64, line 20, leave out
‘the patient after the patient’
and insert ‘P after P’.
No. 87, in schedule 3, page 64, line 23, leave out ‘the patient’ and insert ‘P’.
No. 88, in schedule 3, page 64, line 27, leave out ‘the patient’s’ and insert ‘P’s’.
No. 89, in schedule 3, page 64, line 28, leave out ‘the patient’ and insert ‘P’.
No. 90, in schedule 3, page 64, line 30, leave out
‘the patient is likely to regain’
and insert
‘P is likely at some time to have’.
No. 91, in schedule 3, page 64, line 31, leave out ‘the patient’s’ and insert ‘P’s’.
No. 92, in schedule 3, page 64, line 33, leave out ‘the patient’ and insert ‘P’.
No. 93, in schedule 3, page 64, line 34, leave out
‘the patient has not, after regaining’
and insert
‘P has not subsequently, at a time when P has’.
No. 94, in schedule 3, page 64, line 38, leave out ‘the patient’ and insert ‘P’.
No. 95, in schedule 3, page 64, line 40, leave out ‘the patient’ and insert ‘P’.
No. 96, in schedule 3, page 64, line 42, leave out ‘the patient’ and insert ‘P’.
No. 97, in schedule 3, page 64, line 45, leave out ‘the patient regaining’ and insert ‘P having’.
No. 98, in schedule 3, page 64, line 46, leave out ‘the patient no longer’ and insert ‘P not’.
No. 99, in schedule 3, page 65, leave out lines 3 to 5.
No. 100, in schedule 3, page 65, line 29, at end insert—
‘(4) If the Authority is satisfied that the parental consent conditions in paragraph 15A are met in relation to the proposed use under a licence of the human cells of a person who has not attained the age of 18 years (“C”), the Authority may in the licence authorise the application of sub-paragraph (5) in relation to C.
(5) Where the licence authorises the application of this sub-paragraph, the effective consent of a person having parental responsibility for C—
(a) to the use of C’s human cells to bring about the creation of a human admixed embryo in vitro for use for the purposes of a project of research, or
(b) to the use for those purposes of a human admixed embryo in relation to which C is a relevant person by reason only of the use of C’s human cells,
is to be treated for the purposes of sub-paragraphs (1) to (3) as the effective consent of C.
(6) If C attains the age of 18 years or the condition in paragraph 15A(3) ceases to be met in relation to C, paragraph 4 has effect in relation to C as if any effective consent previously given under sub-paragraphs (1) to (3) by a person having parental responsibility for C had been given by C but, subject to that, sub-paragraph (5) ceases to apply in relation to C.
(7) Sub-paragraphs (1) to (3) have effect subject to paragraphs 15B and 15F.’.
No. 101, in schedule 3, page 65, line 36, at end insert—
‘(2) Where a licence authorises the application of paragraph 13(5) in relation to a person who has not attained the age of 18 years (“C”), the effective consent of a person having parental responsibility for C to the storage of a human admixed embryo in relation to which C is a relevant person by reason only of the use of C’s human cells is to be treated for the purposes of sub-paragraph (1) as the effective consent of C.
(3) If C attains the age of 18 years or the condition in paragraph 15A(3) ceases to be met in relation to C, paragraph 4 has effect in relation to C as if any effective consent previously given under sub-paragraph (1) by a person having parental responsibility for C had been given by C but, subject to that, sub-paragraph (2) ceases to apply in relation to C.
(4) Sub-paragraph (1) has effect subject to paragraphs 15B and 15F.’.
No. 102, in schedule 3, page 66, line 5, at end insert—

‘Cases where human cells etc. can be used without consent of person providing them
After paragraph 15 (as inserted by paragraph 13 above) insert—

“Parental consent conditions
15A (1) In relation to a person who has not attained the age of 18 years (“C”), the parental consent conditions referred to in paragraphs 6(3ZA) and 13(4) are as follows.
(2) Condition A is that C suffers from, or is likely to develop, a serious disease, a serious physical or mental disability or any other serious medical condition.
(3) Condition B is that either—
(a) C is not competent to deal with the issue of consent to the use of C’s human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research, or
(b) C has attained the age of 16 years but lacks capacity to consent to such use of C’s human cells.
(4) Condition C is that any embryo or human admixed embryo to be created in vitro is to be used for the purposes of a project of research which is intended to increase knowledge about—
(a) the disease, disability or medical condition mentioned in sub-paragraph (2) or any similar disease, disability or medical condition, or
(b) the treatment of, or care of persons affected by, that disease, disability or medical condition or any similar disease, disability or medical condition.
(5) Condition D is that there are reasonable grounds for believing that research of comparable effectiveness cannot be carried out if the only human cells that can be used to bring about the creation in vitro of embryos or human admixed embryos for use for the purposes of the project are the human cells of persons who—
(a) have attained the age of 18 years and have capacity to consent to the use of their human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of the project, or
(b) have not attained that age but are competent to deal with the issue of consent to such use of their human cells.
(6) In relation to Scotland, sub-paragraphs (1) to (5) are to be read with the following modifications—
(a) for sub-paragraph (3) substitute—
“(3) Condition B is that C does not have capacity (within the meaning of section 2(4ZB) of the Age of Legal Capacity (Scotland) Act 1991) to consent to the use of C’s human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research.”,
(b) in sub-paragraph (5)(a), for “have capacity to consent” substitute “are not incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of giving consent”, and
(c) in sub-paragraph (5)(b), for “are competent to deal with the issue of” substitute “have capacity (within the meaning of section 2(4ZB) of the Age of Legal Capacity (Scotland) Act 1991) to”.

Adults lacking capacity: exemption relating to use of human cells etc.
15B (1) If, in relation to the proposed use under a licence of the human cells of a person who has attained the age of 18 years (“P”), the Authority is satisfied—
(a) that the conditions in paragraph 15C are met,
(b) that paragraphs (1) to (4) of paragraph 15D have been complied with, and
(c) that the condition in paragraph 15D(5) is met,
the Authority may in the licence authorise the application of this paragraph in relation to P.
(2) Where a licence authorises the application of this paragraph, this Schedule does not require the consent of P—
(a) to the use (whether during P’s life or after P’s death) of P’s human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research,
(b) to the storage or the use for those purposes (whether during P’s life or after P’s death) of an embryo or human admixed embryo in relation to which P is a relevant person by reason only of the use of P’s human cells.
(3) This paragraph has effect subject to paragraph 15E.

Consent to use of human cells etc. not required: adult lacking capacity
15C (1) The conditions referred to in paragraph 15B(1)(a) are as follows.
(2) Condition A is that P suffers from, or is likely to develop, a serious disease, a serious physical or mental disability or any other serious medical condition.
(3) Condition B is that P lacks capacity to consent to the use of P’s human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research.
(4) Condition C is that the person responsible under the licence has no reason to believe that P had refused such consent at a time when P had that capacity.
(5) Condition D is that it appears unlikely that P will at some time have that capacity.
(6) Condition E is that any embryo or human admixed embryo to be created in vitro is to be used for the purposes of a project of research which is intended to increase knowledge about—
(a) the disease, disability or medical condition mentioned in sub-paragraph (2) or any similar disease, disability or medical condition, or
(b) the treatment of, or care of persons affected by, that disease, disability or medical condition or any similar disease, disability or medical condition.
(7) Condition F is that there are reasonable grounds for believing that research of comparable effectiveness cannot be carried out if the only human cells that can be used to bring about the creation in vitro of embryos or human admixed embryos for use for the purposes of the project are the human cells of persons who—
(a) have attained the age of 18 years and have capacity to consent to the use of their human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of the project, or
(b) have not attained that age but are competent to deal with the issue of consent to such use of their human cells.
(8) In this paragraph and paragraph 15D references to the person responsible under the licence are to be read, in a case where an application for a licence is being made, as references to the person who is to be the person responsible.
(9) In relation to Scotland—
(a) references in sub-paragraphs (3) to (5) to P lacking, or having, capacity to consent are to be read respectively as references to P being, or not being, incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of giving such consent, and
(b) sub-paragraph (7) is to be read with the following modifications—
(i) in paragraph (a), for “have capacity to consent” substitute “are not incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of giving consent”, and
(ii) in paragraph (b), for “are competent to deal with the issue of” substitute “have capacity (within the meaning of section 2(4ZB) of the Age of Legal Capacity (Scotland) Act 1991) to”.

Consulting carers etc. in case of adult lacking capacity
15D (1) This paragraph applies in relation to a person who has attained the age of 18 years (“P”) where the person responsible under the licence (“R”) wishes to use P’s human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research, in a case where P lacks capacity to consent to their use.
(2) R must take reasonable steps to identify a person who—
(a) otherwise than in a professional capacity or for remuneration, is engaged in caring for P or is interested in P’s welfare, and
(b) is prepared to be consulted by R under this paragraph of this Schedule.
(3) If R is unable to identify such a person R must nominate a person who—
(a) is prepared to be consulted by R under this paragraph of this Schedule, but
(b) has no connection with the project.
(4) R must provide the person identified under sub-paragraph (2) or nominated under sub-paragraph (3) (“F”) with information about the proposed use of human cells to bring about the creation in vitro of embryos or human admixed embryos for use for the purposes of the project and ask F what, in F’s opinion, P’s wishes and feelings about the use of P’s human cells for that purpose would be likely to be if P had capacity in relation to the matter.
(5) The condition referred to in paragraph 15B(1)(c) is that, on being consulted, F has not advised R that in F’s opinion P’s wishes and feelings would be likely to lead P to decline to consent to the use of P’s human cells for that purpose.
(6) In relation to Scotland, the references in sub-paragraphs (1) and (4) to P lacking, or having, capacity to consent are to be read respectively as references to P being, or not being, incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of giving such consent.

Effect of acquiring capacity
15E (1) Paragraph 15B does not apply to the use of P’s human cells to bring about the creation in vitro of an embryo or human admixed embryo if, at a time before the human cells are used for that purpose, P—
(a) has capacity to consent to their use, and
(b) gives written notice to the person keeping the human cells that P does not wish them to be used for that purpose.
(2) Paragraph 15B does not apply to the storage or use of an embryo or human admixed embryo whose creation in vitro was brought about with the use of P’s human cells if, at a time before the embryo or human admixed embryo is used for the purposes of the project of research, P—
(a) has capacity to consent to the storage or use, and
(b) gives written notice to the person keeping the human cells that P does not wish them to be used for that purpose.
(3) In relation to Scotland, the references in sub-paragraphs (1)(a) and (2)(a) to P having capacity to consent are to be read as references to P not being incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of giving such consent.

Use of cell lines in existence before relevant commencement date
15F (1) Where a licence authorises the application of this paragraph in relation to qualifying cells, this Schedule does not require the consent of a person (“P”)—
(a) to the use of qualifying cells of P to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of a project of research, or
(b) to the storage or the use for those purposes of an embryo or human admixed embryo in relation to which P is a relevant person by reason only of the use of qualifying cells of P.
(2) “Qualifying cells” are human cells which—
(a) were lawfully stored for research purposes immediately before the commencement date, or
(b) are derived from human cells which were lawfully stored for those purposes at that time.
(3) The “commencement date” is the date on which paragraph 9(2)(a) of Schedule 3 to the Human Fertilisation and Embryology Act 2008 (requirement for consent to use of human cells to create an embryo) comes into force.

Conditions for grant of exemption in paragraph 15F
15G (1) A licence may not authorise the application of paragraph 15F unless the Authority is satisfied—
(a) that there are reasonable grounds for believing that scientific research will be adversely affected to a significant extent if the only human cells that can be used to bring about the creation in vitro of embryos or human admixed embryos for use for the purposes of the project of research are—
(i) human cells in respect of which there is an effective consent to their use to bring about the creation in vitro of embryos or human admixed embryos for use for those purposes, or
(ii) human cells which by virtue of paragraph 15B can be used without such consent, and
(b) that any of the following conditions is met in relation to each of the persons whose human cells are qualifying cells which are to be used for the purposes of the project of research.
(2) Condition A is that—
(a) it is not reasonably possible for the person responsible under the licence (“R”) to identify the person falling within sub-paragraph (1)(b) (“P”), and
(b) where any information that relates to P (without identifying P or enabling P to be identified) is available to R, that information does not suggest that P would have objected to the use of P’s human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of the project.
(3) Condition B is that—
(a) the person responsible under the licence (“R”) has taken all reasonable steps to contact the person falling within sub-paragraph (1)(b) (“P”) but has been unable to do so,
(b) R does not have any reason to believe P to have died, and
(c) the information relating to P that is available to R does not suggest that P would have objected to the use of P’s human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of the project.
(4) Condition C is that—
(a) the person falling within sub-paragraph (1)(b) (“P”) has died since P’s human cells were first stored,
(b) the information relating to P that is available to the person responsible under the licence (“R”) does not suggest that P would have objected to the use of P’s human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of the project, and
(c) a person who stood in a qualifying relationship to P immediately before P died has given consent in writing to the use of P’s human cells to bring about the creation in vitro of an embryo or human admixed embryo for use for the purposes of the project.
(5) The HTA consent provisions apply in relation to consent for the purposes of sub-paragraph (4)(c) as they apply in relation to consent for the purposes of section 3(6)(c) of the Human Tissue Act 2004; and for the purposes of this sub-paragraph the HTA consent provisions are to be treated as if they extended to Scotland.
(6) In sub-paragraph (5) “the HTA consent provisions” means subsections (4), (5), (6), (7) and (8)(a) and (b) of section 27 of the Human Tissue Act 2004.
(7) In this paragraph references to the person responsible under the licence are to be read, in a case where an application for a licence is being made, as references to the person who is to be the person responsible.
(8) Paragraphs 1 to 4 of this Schedule do not apply in relation to a consent given for the purposes of sub-paragraph (4)(c).”’.
No. 103, in schedule 3, page 66, line 31, at end insert—
‘(5) References in this Schedule to parental responsibility are—
(a) in relation to England and Wales, to be read in accordance with the Children Act 1989,
(b) in relation to Northern Ireland, to be read in accordance with the Children (Northern Ireland) Order 1995, and
(c) in relation to Scotland, to be read as references to parental responsibilities and parental rights within the meaning of the Children (Scotland) Act 1995.
(6) References in this Schedule to capacity are, in relation to England and Wales, to be read in accordance with the Mental Capacity Act 2005.
(7) References in this Schedule to the age of 18 years are, in relation to Scotland, to be read as references to the age of 16 years.’.—[Dawn Primarolo.]

Question proposed, That this schedule, as amended, be the Third schedule to the Bill.

Evan Harris: I have six brief issues to raise. I apologise to the Committee for having read the schedule, which is where I went wrong. I was hoping that the Committee could get away earlier.
My first question relates to the provisions on page 60 of the Bill, which amend paragraph 2 of schedule 3 to the 1990 Act. I was hoping that the Minister would explain the purpose of that measure and, in particular, whether it conflicts with a later paragraph—paragraph 6(4) of schedule 3 to the Bill, which is also on page 60 of the Bill and which introduces new sub-paragraph (3) to existing paragraph 4 of the 1990 Act. It states:
“Where the terms of any consent to the use of an embryo...include consent to the use of an embryo or human admixed embryo whose creation may be brought about in vitro using embryo A, that consent to the use of that subsequent embryo or human admixed embryo cannot be varied or withdrawn once embryo A has been used for one or more of the purposes mentioned in sub-paragraph (2)(a) or (b).”
Sub-paragraphs (2)(a) and (b) relate to treatment services and projected research.
Substituted sub-paragraph (5) on page 60 of the Bill states:
“In the case of a consent falling within sub-paragraph (4)(b), the terms of the consent may be varied, or the consent may be withdrawn, in accordance with this Schedule either generally or in relation to—
(a) a particular embryo or particular embryos, or
(b) a particular human admixed embryo or particular human admixed embryos.”
I just want reassurance. I do not have significant doubts that the Bill as amended is correct and that the Act will be correct, but it is not obvious—nor was I able to find it in the explanatory notes—why it seems that people can pick and choose their consent and withdraw consents around embryos, whereas elsewhere it says that they cannot withdraw once the process has been started.
I can understand why people do not want the expense of a research project doing something and consent being retrospectively withdrawn in the middle of the project. It just seems to me that there may be some inconsistency. I hope that I have explained that.

Mark Simmonds: Has the hon. Gentleman noticed in the explanatory notes the phrase “chain of consent”, which relates to paragraph 14 of schedule 3 to the Bill? It may go some way to shining light on the area he is discussing.

Evan Harris: I am grateful to the hon. Gentleman for suggesting that this issue is more complex even than that. That may be the solution or it may be an extra complexity. I am sure that some reading will have to be done.
My next point relates to the concern around proposed new sub-paragraph (5), which is inserted by paragraph 6 of schedule 3 to the Bill. It can be found at the top of page 61, in line 5. The distinction is between the way that this is dealt with for embryos and the way it is handled for human admixed embryos. Paragraph 4(2) of schedule 3 as it will be amended states:
“Subject to sub-paragraph (3), the terms of any consent to the use of an embryo”
—that is, not human admixed embryo—
“cannot be varied, and such consent cannot be withdrawn, once the embryo has been used—
(a) in providing treatment services”,
which clearly does not apply to human admixed embryos, which is why it is a different construction in sub-paragraph (5) of the measure as it will be amended, or
“(aa) in training persons in embryo biopsy, embryo storage or other embryological techniques”,
which is the problem.

Ian Gibson: Could the hon. Gentleman take it more slowly, please? It is impossible to follow, and we are trying hard to do our job.

Evan Harris: I will try to oblige. I would like to refer to paragraph 6 of schedule 3, in particular to draw attention to the impact of sub-paragraph (3) in amending paragraph 4(2) of the schedule to the Act, because the schedule to the Bill amends the schedule to the Act. I would like to contrast that with what paragraph 6(5) of schedule 3 to the Bill does to the same paragraph—that is, paragraph 4 of the schedule to the Act—when it inserts sub-paragraph (5). This can be found near the top of page 61 of the Bill. It deals with human admixed embryos.
My point was that paragraph 4(2) of the schedule to the Act, as amended, would say that
“the terms of any consent to the use of any embryo, that is, not human admixed embryo (“embryo A”)”
—that is, not “human admixed embryo”—
“cannot be varied, and such consent cannot be withdrawn, once the embryo has been used—
(a) in providing treatment services”.
That, rightly, does not appear for the human admixed embryos in paragraph 5, because there is no question of human admixed embryos being used for treatment services,
“(aa) In training persons in embryo biopsy, embryo storage or other embryological techniques,”
which is not covered in sub-paragraph (5) and which I am suggesting could usefully be done, and
“(b) for the purposes of any project of research.”
Paragraph 5(4), which is shorter, now states:
“Where the terms of any consent to the use of a human admixed embryo (“human admixed embryo A”) include consent to the use of a human admixed embryo or embryo whose creation may be brought about in vitro using human admixed embryo A, that consent to the use of that subsequent human admixed embryo or embryo cannot be varied or withdrawn once human admixed embryo A has been used for the purposes of any project of research.”
I may be wrong, because that deals with a chain of embryos and “any embryo” may cover “human admixed embryo”, but what concerns me is that there does not seem to be provision for human admixed embryos to be used for training people in the handling of blastocysts, if it is possible to create a blastocyst, and in things to do with embryological storage. One of the reasons for introducing human admixed embryos is a shortage of eggs, and it may well be that there is no better use of a human admixed embryo than for training, since it preserves the use of eggs and precious embryos, which should be used in treatment services, for those purposes.
However, I feel that there may be something missing, which relates to the third point I want to make. I may be wrong—I usually am, when it comes to questioning Government amendments to complex pieces of legislation—but amendment No. 66, which I will not be speaking to, does not seem fully to amend the schedule. The Committee will notice that amendment No. 66 inserts “(ba)” into line 12 on page 62 of schedule 3, but it does not amend line 8, and line 8 would appear to have an amendable part—that is, the insertion of “(ba)” into line 8. The effect of not amending paragraph 6 in schedule 3 to the Act as amended is that:
“A person’s gametes or human cells must not be used to bring about the creation of any embryo in vitro unless there is an effective consent by that person to any embryo, the creation of which may be brought about with the use of those gametes or human cells, being used for one or more of the purposes mentioned in paragraph 2(1)(a), (b) and (c)”.
That does not include testing. However, the Government are seeking to amend the Act with the amendment to schedule 3:
“An embryo the creation of which was brought about in vitro must not be received by any person unless there is an effective consent by each relevant person in relation to the embryo to the use of one or more of the purposes mentioned in paragraph 2(1)(a), (b)”
—it is now (ba)—“and (c)”.
Perhaps for training purposes it is a matter of receipt rather than use, but I am not certain of that. I would be grateful if the Minister could clarify whether that is an omission.
My fourth point is to ask the Minister whether she can explain what is meant by paragraph 10 of schedule 3 on page 62. It is about the use of embryos obtained by lavage. The explanatory notes specify that its purpose is to prevent embryos taken from a woman being used in research, but perhaps the Minister could explain why it was felt necessary to have it in the Bill now. Was there a gap? What was the impact of that gap? What could have happened had the provision not been introduced? It was mentioned briefly in the other place, but on reading it in Hansard, it was not entirely clear what it meant.
My fifth point is one that I raised incorrectly in consideration of the amendments, and the Minister did not address it in her comments. On page 64, paragraph 10(3)(b), there is a provision to ensure that consent is not required for storage. It states that the position meant is one where
“the patient is likely to regain that capacity”.
My point was whether “likely” is the right test given that it suggests a greater than 50 per cent. chance, two thirds of a chance, that capacity will be restored. Sometimes it is impossible to say whether it will be restored; in some circumstances it is possible but unlikely. Where is that dividing line to be drawn? It would be helpful if the Minister could give some indication, now or at a later stage, about what she means.
My final point is to draw an issue to the attention of the Minister. This is for information only—I do not expect her to respond. On page 65, proposed new paragraph 13(1) at line 16, the discussion about human admixed embryos describes them as being used for the purposes of “any project of research”, and it is the same in line 21. That provides a mismatch, which we discussed earlier with respect to the earlier part of the schedule in the first group of amendments.
A similar problem arises in schedule 2 about the issue of testing on human admixed embryos. I do not believe that schedule 2 has been amended to provide for the use of human admixed embryos in the testing of embryos. Obviously, I cannot talk about schedule 2 now as it was considered in Committee on the Floor of the House, but I draw attention to the fact that if the Government are right, they are right in both places and if there is a problem, it may apply in both places.

Mark Simmonds: I am sure that hon. Members who thought that they understood how consents were going to work are now completely confused, as indeed am I. I wish to make three succinct points, the first of which is about written consent that will be rightly retained and also the consent that must be signed under the Bill. Can the Minister say whether there is evidence that written, but unsigned, consent—as under the 1990 Act—has led to misuse, or inappropriate use or storage of gametes and embryos? My second point relates to paragraph 4(3) of the 1990 Act and the withdrawing of consent. I see no mention in the Bill of those who are physically incapacitated who wish to withdraw and direct another to sign on their behalf. If I have interpreted the Bill correctly, such people can do so in respect of consent, but not for withdrawal. Why is that the case?
My third point follows that made by the hon. Member for Oxford, West and Abingdon. It would be helpful if the Minister could clarify the specific nature of consents under paragraph 8. Are separate consents required for the storage of gametes and for the embryo created by the gametes, as they are for admixed embryos? Such matters might be explained by the phrase “the chain of consent” that is used in the explanatory notes, which—to be fair—is why the hon. Gentleman could not find it. The reference to that is in paragraph 89 of the explanatory notes.

Dawn Primarolo: I had no idea that the hon. Member for Oxford, West and Abingdon aspired to be a parliamentary draftsman. If that is the career he is heading towards, he has demonstrated his ability well this afternoon, although one of the enormous skills of parliamentary counsel is—thank goodness—to listen carefully and have specific instructions about intent and what is expected under the law, and make sure that it is covered. As the hon. Gentleman progressed through his questions, he answered them.
The hon. Gentleman said that the schedule is about enabling a person to give either general consent about how an embryo may be used or specific consent in relation to a particular embryo. Consent can therefore be specific. The provision needs to reflect all of that and show that, having given general consent, a person can vary it or withdraw any of their consents. However, that is limited by paragraph 4 under which consent cannot be withdrawn when an embryo has been used and has progressed a long way into a research project. All the references that the hon. Gentleman made to the schedule picked up each one of those interactions and reinforced them. That is the only way in which to handle matters and I am sure that the parliamentary draftsmen will be fascinated to read how closely he has followed the accuracy of their drafting. Many people with fantastic qualifications, along with the hon. Gentleman and his considerable skills, have examined the Bill to see that that is what it will deliver.
The hon. Gentleman thought that a reference was missing in respect of training. He is not right. If he passes his mind back to our earlier debate, embryos cannot be created for the purpose of training. The reference is not missing because such action cannot take place. The Government do not intend embryos to be created for training alone; they can be used for training and that is covered under paragraph 6(3). There is no omission there either. Of course, training is part of a treatment licence. It is not possible for a licence to be granted for training in connection with human admixed embryos under schedule 2. That is reflected in schedule 3, which is why there is no consent provision; it cannot be done in the first place.
The hon. Gentleman returned to a point that we debated concerning amendment (b) to Government amendment No. 102, which specifically touched on a research project. I have already told him that I would consider that point.
The hon. Member for Boston and Skegness—

Evan Harris: I am sorry, but I think that there has been a misreading. I do not think that amendment (b) to Government amendment No. 102 has anything to do with the issues that I raised about the limitations on research and the threshold that research must reach. I think that the Minister might be referring to another amendment, although I do not think that it was amendment (b).
Is it the Minister’s understanding that it will not be possible for human admixed embryos to be used in a research project for training—they can obviously be used only for research—or does she consider that training is an integral part of research and that there will therefore not be a problem training new researchers in how to manipulate human admixed embryos? It that was the case, it might be helpful if she would specify that.

Dawn Primarolo: I thought that I had made it clear during a previous debate that the Government see training as an integral part of research. We do not see the necessity for a licence for training only and we do not permit that.
With regard to the point made by the hon. Member for Boston and Skegness, I am not aware that there has ever been an issue about unsigned consents, so I cannot specifically reassure him on that point. I suppose that it is a bit of a reassurance to say that there has never been such an issue, but I will go back and double check on that point.

Mark Simmonds: If that is the case—I am sure that the Minister is correct—it gives rise to a question about the necessity of adding a signature to a system that is working perfectly well already.

Dawn Primarolo: I am sure that the hon. Gentleman would accept that if a signature were made explicit, most of us would sign consent automatically. However, I cannot tell him whether we have ever had a consent that has not been signed. The point is to make it explicit. However, in this matter, we would all ensure that we signed it, particularly bearing in mind that that could have implications for future research. As my right hon. Friend the Member for Coatbridge, Chryston and Bellshill said, there might be areas of research to which we would not want to consent. I will return to the matter, but I am unable at the moment to give the hon. Gentleman specific details at the moment.

Evan Harris: I raised six points. The Minister has said that the first one arose due to a misunderstanding of intention and I shall look at what she has said. I accept that she has dealt with the second and third points in respect of training matters.
I asked whether the Minister could give an explanation on the provisions on lavage, and the hon. Member for Boston and Skegness, who can speak for himself, indicated that he was also interested in that answer. I have also raised substantively—twice—the threshold for the patient being likely to regain capacity in respect of amended paragraph 10 of schedule 3 to the 1990 Act. I would be grateful if the Minister could respond to those two issues only, having had her amusing fun with my asking questions about the schedule.

Dawn Primarolo: I have answered the hon. Gentleman’s questions specifically with regard to consent and to that point. I put all his points together by explaining how they interact in the schedule. If the hon. Gentleman is still dissatisfied after reading Hansard, I will be more than happy to correspond with him and make sure that the letters are circulated to every member of the Committee. I am not trying to avoid answering his questions, but if he wants complex answers about the interaction of a whole range of things with which he can be satisfied, he could always give me notice. That would ensure that I understood before he said it, as well as when he said it, exactly what was his intention so that I would not misinterpret it.
The hon. Member for Boston and Skegness raised a point about the amendment to paragraph 4 of schedule 3 to the 1990 Act concerning whether people who are physically incapacitated can withdraw consent. Yes, they can. Provision is made in paragraph 3 of schedule 3 to the Bill, which amends paragraph 1 of schedule 3 to the 1990 Act. I hope that he will be able to reflect on that after the Committee, and if he is still not satisfied, I would, of course, be happy to come back to him.

Evan Harris: The record will show that I made no criticism of the Minister either in my opening remarks or in my intervention. I accept that the first point that I raised was about a complex interaction, and I did not expect her necessarily to be able to satisfy me on that.
I am grateful to the Minister for explaining the position with regard to testing, which was not immediately apparent to me in respect of human admixed embryos. More importantly, she explained that under this regime, training was very clearly going to be permitted on human admixed embryos and that it was part and parcel of the research licence. I am not the only person who has expressed concerns about this—people working in the field want clarification—so I am grateful to her for that.
I did not think, however, that it was unreasonable to ask for an explanation of paragraph 10 of the schedule. The explanatory notes merely say:
“Paragraph 7 of Schedule 3 to the 1990 Act is amended by paragraph 10 of Schedule 3 to the Bill to prohibit the use of an embryo taken from a woman to create an embryo in vitro or to create a human admixed embryo in vitro.”
I merely asked whether this was just tidying up, or whether there had been a problem or a concern expressed and what was the mischief that this was seeking to amend.

Dawn Primarolo: And I did answer the hon. Gentleman’s point. I say again that this relates to the question of consent that is in the 1990 Act regarding women and lavage. Paragraph 10 simply makes it clear that that has not been superseded. It makes it clear that the embryo taken from the woman is tied up with questions of consent, in general or specifically. It cannot be used to create a human admixed embryo, so the consent on that issue in the 1990 Act is linked to this schedule. That is the answer that I gave him.

Evan Harris: If that is the case, I am grateful to the Minister for reiterating that and I will go away and study that.
Finally, I have raised three times now the position of a patient likely to regain capacity and whether we have the correct threshold. I do not think that this is a question of interaction or of how the consent arrangements fall. There is a specific provision. I wish to ask whether there will be patients in certain conditions in which it will be very difficult to judge whether “likely” is the right test. I think that that will create problems, and it struck me that it might be possible, before the Bill completes its passage, to provide clarity on that.

Question put and agreed to.

Schedule 3, as amended, agreed to.

Schedule 4

Schedule inserted in the 1990 Act as Schedule 3ZA

Question proposed, That the schedule be the Fourth schedule to the Bill.

Mark Simmonds: I have one or two questions for the Minister about counselling and the circumstances in which it should be offered. I certainly do not believe that counselling should be mandatory, but it should be offered and it should be effective. It is important that counselling is provided by skilled professionals who are experienced in such matters, so I have some questions.
Do counsellors working in this field have specialised training or expertise, or are they counsellors in other areas as well? Is there a division between counsellors who work with people undergoing treatment and counsellors who work with those who have donated gametes? Are they different kinds of counsellors who require different training, or do they come from the same generic group of individuals? Is there any charge for the counselling service? If so, is it merely a charge to recoup the costs, or is it a revenue-generating exercise as well? Finally, are the guidelines set by the HFEA, or is it up to each individual clinic to set its own guidelines?

Dawn Primarolo: On the question of the fee, the cost of counselling is covered in the cost of the treatment services—it is all wrapped up. On the question of who sets the guidelines, a code of practice is set as guidance for clinics on how to offer counselling. The code states specifically that patients need to be aware of the offer, that it needs to be routine, that it should include written information and that it should give the names of qualified counsellors in the area, who may also have wider qualifications. The counsellor’s role needs to be explained, as well as when they are available and how to access the service. Obviously, there should be no pressure to accept counselling, but sufficient time should be given to consider the offer.
I am afraid that I do not know the answer to the hon. Gentleman’s question about the division of counsellors’ roles, so I will have to write to him. The HFEA sets the code of practice, counselling is included within the cost of treatment, and counsellors need to be specialised. I will respond to his last point as soon as I can.

Question put and agreed to.

Schedule 4 agreed to.

Clause 15

Conditions of storage licences

Mark Simmonds: I beg to move amendment No. 5, in clause 15, page 11, line 47, leave out ‘ten’ and insert ‘seven’.

Roger Gale: With this it will be convenient to discuss amendment No. 34, in clause 15, page 12, line 3, leave out ‘ten’ and insert ‘seven’.

Mark Simmonds: Amendment No. 34 is a consequential amendment to amendment No. 5, so I shall concentrate on the latter. It is, I acknowledge, a further probing amendment, which relates to how long gametes and embryos can be kept in storage. At the moment, embryos can be kept for five years, and then for five years beyond that, if the couple chooses. Will the Minister put on record what evidence exists that embryos and gametes are of sufficient quality after and up to 10 years? For how long afterwards does she believe that embryos can be kept in storage without deteriorating, if there is indeed evidence to support that?
Is the Minister concerned that removing the five-year break will result in fewer couples giving their embryos for research as they will not necessarily be reminded of the possibility after the five years? As the 1990 Act lasted for 18 years, I think that the general view in the Committee is that we wish this Bill, after it becomes an Act, to last similarly long. Is it possible to change the time period under regulation if future techniques allow longer storage?
I think that a recent case forms the basis of an amendment that has been tabled by the hon. Member for Oxford, West and Abingdon. A young girl, because of treatment she has received, will not be able to have children later on in life. However, she is of such a young age that even if her mother donates an egg for her now, after the 10-year period has elapsed, she will still not be old enough to have a child. Regulations might allow that situation to be changed as scientific techniques develop and, again, it could be amended by new clause 2, which was tabled by the hon. Gentleman.

Dawn Primarolo: I recognise that limits on the storage of gametes and embryos can cause some concern. The length of storage needs to ensure fairness, while also taking into account the safety of freezing. I believe that the statutory 10-year period for gametes, with extended storage for medical reasons, remains appropriate. I also consider that the same limits should be applied to embryos. Therefore, the Bill brings storage limits into line with each other.
The Warnock report proposed a 10-year period. I suppose that the hon. Gentleman is quite right about which years one picks—it is arbitrary. Five years was the decision of Parliament. In the 24 years since the report was published, there has been no body of evidence to suggest that using embryos that have been frozen for 10 years endangers a mother or child. There is a possibility of change—the hon. Gentleman pointed to the regulating power—enabling an extension beyond 10 years in specific circumstances, but that is something that would need to be considered later. At this point, because we can see that there is an application to go further, it seems sensible to go for 10 years. I suppose that his guess might be as good as anyone else’s. That is the reason for settling at 10 years, but allowing variation under specific circumstances and having the regulatory power in place, if it is necessary to extend it further in the future.

Mark Simmonds: I am grateful to the Minister for that explanation and for the confirmation that there are regulatory powers for changing what is in the Bill, if scientific advancement allows. In that context, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Question proposed, That the clause stand part of the Bill.

Roger Gale: With this it will be convenient to discuss new clause 2—Extension of statutory storage period for treatment of blood relatives
‘(1) The Human Fertilisation and Embryology (Statutory Storage Period) Regulations (S.I. 1991/1540) are amended as follows.
(2) In regulation 2(1) for “paragraph (2)” substitute “paragraphs (2) and (2A)”.
(3) After regulation 2(2) insert—
“(2A) The circumstances referred to in paragraph (1) are that the gametes were provided by a person who has given written consent for them to be used by another person—
(a) who is a blood relative of the person providing the gametes,
(b) whose fertility was, in the written opinion of a registered medical practitioner, significantly impaired on the date on which the gametes were provided, and
(c) who was aged under 45 on the date on which the gametes were provided.”.’.

Evan Harris: I wanted to draw attention to something that has already been touched upon: a problem with not only the current storage legislation, but the regulations. The Minister will be aware of the case that I am going to cite on behalf of my hon. Friend the Member for Hazel Grove (Andrew Stunell), who has been assiduously pursuing the issue for one of his constituents. He raised it on Second Reading and wrote to the Minister on 14 May to set out the problems. I thought that it would be useful to summarise the situation and to quote from that letter, with the permission of my hon. Friend.
The problem is that the regulations for storing gametes were set by the Human Fertilisation and Embryology (Statutory Storage Periods) Regulations 1991, which could, in theory, be amended under the current Bill. In this case, there is a woman whose daughter suffers from Turner syndrome. That is not life-threatening—a relatively normal life can be led with treatment—but one of its features is infertility. In this case, the mother wishes to donate her own eggs so that her daughter will be able to have children by IVF treatment in the future. The problem is that the time limit for storing gametes is set at 10 years. Regulations state that gametes must be donated before the donor reaches the age of 36, which creates a problem in this family and, presumably, others. If the mother donated before the age of 36, the 10 years would expire when her daughter was still only 18 and therefore extremely unlikely to be ready to use the eggs.
The Committee will be aware that the current regulations provide for an exception if the gametes are stored for the use of the donor. However, according to a letter received by my hon. Friend the Member for Hazel Grove from the HFEA, the reason for the 10-year limit is that it is best if clinics are not overburdened by the number of samples in storage. I accept that there is a regulatory issue, so the question is whether there could be exceptional circumstances in which samples might be permitted to be stored for longer than 10 years, for example if donated eggs are intended for another family member who is infertile, which is the case that my hon. Friend has made in a number of forums. Would new clause 2 achieve that? If not, might an amended version?
There is discretion on retrieving eggs after the age of 36. In exceptional circumstances, clinics can use eggs from women over the age of 36, but I think that everyone is aware—the Minister is, of course—that fertility and thus the efficacy of the treatment diminishes rapidly after that point.
Even if the drafting of new clause 2 is not perfect—if there are imperfections, it is through no fault of my hon. Friend—I hope that its intention is clear. It states that an exception can be made when a person
“has given written consent for them to be used by another person...(a) who is a blood relative of the person providing the gametes...(b) whose fertility was, in the written opinion of a registered medical practitioner, significantly impaired on the date on which the gametes were provided, and...(c) who was aged under 45 on the date on which the gametes were provided.”
This is not a unique case—I am conscious of the fact that we should not legislate to provide for an individual case—and I wonder whether an amendment could be made. Obviously, we do not need primary legislation, so I would understand if the Minister said that the Government wished to consider the matter themselves and introduce their own regulations to allow for an exception.

Mark Simmonds: My concern with new clause 2 is about the extremely broad nature of the phrase “blood relative”. Has the hon. Gentleman thought about narrowing it down to a sibling, son or daughter of the donor to exclude third cousins twice removed and so on?

Evan Harris: That is a fair point. There are questions about whether the wording is broad. I am not wedded to the wording of the new clause, so I accept that it might need further work. I have never claimed to be a parliamentary draftsman, despite what was said earlier, and I do not seek to be one. My cup overflows already.
I wish to make a further point about surrogacy. I have not tabled an amendment on this, but any provision would be very similar to new clause 2, so the matter relates to this debate. The Human Fertilisation and Embryology (Statutory Storage Period for Embryos) Regulations 1996 specify the period for which gametes and embryos respectively can be stored in cases where the patient is, or will become, permanently infertile. In extending the normal five-year storage period, the regulations enable patients to preserve their last chance to conceive their own genetic child until the female patient in question is approximately aged 55. Although the Bill extends the normal embryo storage period from five to 10 years, which I think is a good idea, it does not amend the special regulations for extended storage. I think there is a case for the regulations to be updated to benefit patients conceiving their own children through surrogacy. Surrogacy patients are explicitly excluded and, in practice, it seems to me—and to those advising me—that it is utterly arbitrary that a woman who has had her ovaries removed due to cancer can store her eggs and embryos until she is 55, but a woman who has had a hysterectomy due to cancer can store her eggs or embryos for only 10 years. That seems to be somewhat unfair, so I was wondering if the Minister would consider there to be scope to bring the situations more into line—if not in this Bill, through regulations.

Dawn Primarolo: I ask the hon. Gentleman not to press new clause 2 to a Division because I think that he raises a number of difficult issues with regard to some aspects of the regulation. As he has pointed out, there are regulation-making powers under the 1990 Act, and the Bill allows changes to regulations, such as those relating to statutory storage periods of gametes.
The hon. Gentleman made the point that it is not always wise to make primary legislation on the basis of one case. Perhaps if I could tell him when the regulations will be available for consideration, he might rightly feel—as I do—that that would be the appropriate place to raise these considerations. New policies will be proposed in regulations and they will need to be consulted on. The timetable for those regulations is such that the drafts will likely be available toward the end of this year.
I think that the points that the hon. Gentleman raises could be appropriately dealt with in that consultation and the consideration of those regulations, rather than through new clause 2, because there will be other points to consider. For example, the hon. Gentleman touched on surrogacy, which is not addressed by the new clause. There might well be other exceptional circumstances, but it would be wise to address them all in one place in the regulations.
I hope the hon. Gentleman and the hon. Member for Hazel Grove accept that the Government see that this issue needs to be addressed and intend to ensure that that happens during the consideration of the regulations, which will take place before the end of the year. That will be the appropriate point of the consultation to add in some of the points that the hon. Gentleman is suggesting.

Evan Harris: I thank the Minister for that response, although she did not necessarily say that she agreed that there should be a solution. I think she did accept that there was a problem in this case.
Dawn Primarolorose—

Evan Harris: I am sorry if I misunderstood.

Dawn Primarolo: No, no, with respect, I do not know whether there will be a solution. I agree with the hon. Gentleman that it would be desirable to find a solution and the appropriate vehicle for this is the regulations. At this time, I do not know, so that is my only point.

Evan Harris: I apologise to the Minister. I am satisfied that she recognises that there is a problem and that she suggests that rather than trying to amend primary legislation through new clause 2, or another version of it, the appropriate time would be either during the drafting of regulations, or their redrafting following the consultation. I am delighted because she has confirmed that there will be a consultation on drafts, which we discussed earlier. That is always good when regulations are being considered because once they are laid, it is impossible to amend them unless the regulations are withdrawn.
I am grateful to the Minister for indicating that she hopes that the drafts will capture, if possible, a solution to a problem that she acknowledges. I am sure that my hon. Friend the Member for Hazel Grove, who might be listening to the debate using new or old technology, will share my gratitude—and, I suspect, that of his constituent—to the Minister for her positive response.

Question put and agreed to.

Clause 15 ordered to stand part of the Bill.

Clause 16

Grant of licence

Amendments made: No. 41, in clause 16, page 12, line 14, at end insert—
‘( ) in paragraph (c), after “application” insert “or a licence under paragraph 3 of that Schedule authorising activities in connection with the derivation from embryos of stem cells that are intended for human application”, ’.
No. 42, in clause 16, page 12, line 15, after ‘(ca)’ insert ‘— (i)’.
No. 43, in clause 16, page 12, line 16, at end insert—
‘(ii) after “that Schedule” insert “authorising activities otherwise than in connection with the derivation from embryos of stem cells that are intended for human application”, and’.—[Dawn Primarolo.]

Clause 16, as amended, ordered to stand part of the Bill.

Clause 17

The person responsible

Mark Simmonds: I beg to move amendment No. 142, in clause 17, page 12, line 23, at end insert—
‘(1A) In subsection (1)(b) for “equipment is” substitute “equipment and premises are”’.
Although the premises would have been inspected before the licence was granted or renewed, it is also important for the person responsible to ensure that the right equipment and parts of the premises are used for each procedure, and that there is no risk of cross-contamination between admixed embryos and IVF embryos, for example. On my visit to the Centre for Life in Newcastle I saw that it undertakes different types of medical research or treatment in separate parts of the same building. It is obviously the responsibility of the licence holder to ensure that there is no transfer or confusion between the two.
There is an inconsistency. There is no mention of equipment and premises in clause 17, yet in clause 18(d) and (e) they are mentioned as specific reasons for the potential revocation of the licence. Will the Minister explain that inconsistency?

Dawn Primarolo: The amendment would add a requirement to section 17 of the 1990 Act to ensure that it would be a duty of the person responsible to secure appropriate premises as well as equipment in which to carry out activities as they are licensed under the Act. Furthermore, the requirements of the Human Fertilisation and Embryology (Quality and Safety) Regulations 2007, which incorporate the European Union tissue and cells directive into the 1990 Act, would apply to any embryos that are intended for human application. The directive made various extensions to licence conditions, which are set out in schedule 3A to the Act and incorporated by section 14A. The provisions ensure that appropriate equipment and materials are used as well as suitable facilities and premises. It means that any licence that relates to gametes and embryos intended for human application must satisfy those conditions. If they do not, they will be in breach of the licence.
I hope that I have put the hon. Gentleman’s mind at rest. The HFEA always ensures that the person responsible will secure the appropriate premises as part of the licence application. The suitability of the premises is already part of the HFEA inspection process so the twin arrangements are catered for and, if that were not the case, it would be a breach of the licence,

Mark Simmonds: I am grateful to the Minister for clarifying the fact that there is not an inconsistency between the two clauses. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 17 ordered to stand part of the Bill.

Clause 18

Revocation and variation of licence

Mark Simmonds: I beg to move amendment No. 143, in clause 18, page 13, line 29, after ‘person’, insert
‘and is so qualified by training and experience’.
The amendment relates to the variation of a licence. Under section 16 of the 1990 Act, the initial applicant had to satisfy the licensing committee that the character, qualifications and experience of the applicant were suitable. My understanding is that, under this Bill, the person to whom the licence is transferred will not need to satisfy the authority that they are anything more than suitable. There is a difference between those two definitions. One could have a suitable character without the required qualifications and necessary experience. Is the Minister happy with that difference? Would she not prefer a more robust system, with a new inspection under the person responsible or the licence holder?
Will the Minister also clarify whether there is a prohibition on the sale of a licence? Can a licence effectively be bought and sold within the context of the criteria I have just mentioned?
I have one further issue with regard to this amendment. In proposed new section 18A(3), a very clear distinction is made between
“the person responsible”
and
“the holder of the licence (if different).”
Will the Minister say how many licences have been granted where the person responsible and the licence holder are not the same person? In the revocation categories, again, it refers only to “the person responsible”, not the licence holder, which implies that one, “the holder of the licence”, is a subset of the other, “the person responsible”. If they are different, why are they not different in the revocation categories, and if they are the same, why is there a distinction in the first part of clause 18?

Roger Gale: The hon. Gentleman has indicated a rather broad range of questions, which effectively constitute a stand part debate. I am perfectly content with that.

Dawn Primarolo: The Bill simplifies provisions in order to allow the HFEA to determine applications by a licence holder in a more flexible manner. However, this does not change the strict criteria for determining whether people are suitable to be the person responsible. That remains the same.
In 2005, the HFEA, in consultation with stakeholders, took a decision to revise its assessment process for the person responsible, and there are now formal assessments to ensure that the designated person is proficient in their role and up to date with the latest developments in their field. This process consists of various assessments that the person must satisfy. For a research licence, for example, the assessment consists of three workbooks that must be completed by the designated responsible person. One is on the regulatory framework, one is on quality management and risk, and the third covers research regulations. The workbooks also include details outlining certain person specifications, including qualifications. They state all relevant medical, biological, scientific or professional healthcare qualifications, and require the applicant to demonstrate experience, including experience and extensive knowledge of fertility-related management, clinical and scientific developments and treatments, including ethical viewpoints.
The hon. Member for Boston and Skegness went on, as he did before, to ask about the process and refusals in varying or revoking a licence. All the decisions relating to granting, revoking, suspending or varying a centre’s licence are taken by the licence committee of the authority, based on inspection. Inspections need to assess quality, effectiveness of the clinical management, and a whole list of things that I will not read into the record. I will write to him about them.
He asked specifically whether a licence could be sold, passed on or transferred to another responsible person. It could be, but the HFEA must approve any transfer of licence, and it would need to be satisfied that the transfer would go to a responsible person and under all the conditions that I have outlined, as agreed after the 2005 consultation process.
I do not know the answer to the hon. Gentleman’s last question about whether there is a difference between a responsible person and a licence holder. I have a feeling that there is not, but I do not want to commit myself unnecessarily to that and I will come back to him. I hope that he is satisfied that measures are still there to ensure that the responsible person is properly qualified and experienced in the relevant fields, and that the HFEA will scrutinise the licence and the responsible person very closely.

Mark Simmonds: I am grateful to the Minister for that reply. The only outstanding issue is the one to which she referred at the end. It would be helpful if after the Committee I could explain to her in more detail what I feel is not consistent. Perhaps I was not clear enough in my explanation—I will not go through it again now, but it is something that should be looked at. I am happy to receive a response from the Minister after she has had a chance to discuss it with her officials and I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 18 ordered to stand part of the Bill.

Clause 19

Procedure for refusal, variation or revocation of licence

Mark Simmonds: I beg to move amendment No. 144, in clause 19, page 15, line 12, leave out subsection (7).

Roger Gale: With this it will be convenient to discuss amendment
No. 145, in clause 19, page 15, line 14, at end insert—
‘(8) Notification to the applicant of a decision whether to grant or refuse a licence must be given within a specified time period to be determined by regulation.’.

Mark Simmonds: Again, I shall be brief; these are probing amendments. Perhaps the Minister could clarify why on page 15 there seems to be some duplication. In clause 19A there are four distinct categories:
“In the case of a decision to grant a licence, the Authority shall give notice of the decision to—
(a) the applicant, and
(b) the person who is to be the person responsible”.
and those seem to be exactly the same for the four categories: granting, revocation and the two types of variation. I understand that in clause 19A(7) a distinction is drawn with subsections (2) and (4), but I cannot see why it is broken down into four distinct categories under 19A and not two or three. The people who must be notified after decisions are taken are exactly the same. That is the purpose of amendment No. 144.
Amendment No. 145 has been tabled because there are clearly delays that can be damaging both to business and research—particularly the latter as research grants elapse after a certain period of time. Under the current provisions, the authority can take as long as it chooses to decide whether to grant or refuse a licence. The amendment would ensure that the authority understands that it would be helpful if a specific time period—specified in the regulations after consultation—could be set out to help provide clarity. Perhaps the Minister and her officials could give that some thought.
Most public bodies have specific time scales within which they must respond. For example, the Department of Health is supposed to respond to correspondence from MPs within 20 days. I am sure that the Minister will be the first to acknowledge that that is not always the case, but attempts are always made to ensure that the time scale is met. There is concern within the industry—if I can call it that—that there may have been unacceptable and unreasonable delays in specific circumstances. I would not seek to specify the time period in the Bill; that will have to come through discussions and be put through regulations after consultation. However, it is a key point and requires addressing.

Dawn Primarolo: I understand the hon. Gentleman’s point perfectly and the reasons why he seeks to set a time limit, or at least to get an indication of one. This issue is often raised. I accept that the HFEA should respond in reasonable time, and recognise that regulations would allow a suitable period to be determined in consultation with interested parties.
However—the hon. Gentleman touched on this, so I think that what I am about to say might help—setting out such a time limit in statute would restrict the HFEA in having the added flexibility that might be needed in certain situations in the more complex licence applications. I can reassure him and the Committee, however, that the HFEA is committed to notifying the applicant of its decision either to grant or refuse a licence within set time scales. It has a self-imposed target of three months for licence applications, and four for any new treatment and storage licences. It is right that we allow it that flexibility.
Over the past 12 months—I accept that this would not necessarily apply to the more complex applications—the HFEA has received three applications for research licences, all of which were processed and decided upon within the required three months. That indicates that currently it is processing applications in a timely fashion, although we would expect it to be thorough as well. I hope that the hon. Gentleman accepts that his probing amendment on time limits is dealt with.
Proposed new section 19 provides that reasons must be given for certain licensing decisions and provides an opportunity for representations to be made before a decision is taken. It sets out the person to whom notice is to be given when the decision is made. The new provisions set it out that if the HFEA agrees to an application from a licence holder or person responsible to vary or revoke, it does not need to give reasons for its decisions when giving notice to the specified persons. That makes sense, because the HFEA is granting what was requested. That measure is aimed at reducing the unnecessary bureaucratic measures that have also been mentioned. When a decision goes against a request, proposed new section 19A(5) will require the applicant to be given reasons for the refusal. I think that that provision satisfies the concerns raised in relation to the amendment.
The hon. Gentleman then asked about the reason for the different categories. It is to cover the different areas—granting, revocation, application or any other variation—so that they are all covered by slightly different notification requirements based on the relevant application. I accept that that might appear more complicated in the Bill, but in practice it will speed up and make clear what applies in the case of different decisions. I hope that that deals with his questions.

Mark Simmonds: Again, I thank the Minister for her response. Amendment No. 144 is really a probing amendment on which she has clearly satisfied me. I hear what the she says about amendment No. 145, but I urge her and the relevant officials in the Department to monitor the situation carefully, because there is concern among those applying for licences.
I am intrigued that the Minister says that there has been no delay in applications in the past 12 months—that is not what people have been telling me. What was the point of Tuesday’s debate on delegated powers to speed up the process, if it does not need speeding up? From what she has said today, the process seems to be working well. I suspect, however, that because of the additional potential licence areas with which the HFEA will have to cope when the Bill is enacted, it will receive more licence applications than it has to date. The situation therefore needs to be monitored carefully.

Dawn Primarolo: I hope that I did not convey any complacency in explaining what has happened in the 2007-08 period. I accept that comments have been made, and the hon. Gentleman is right about needing to be vigilant and ensuring that the process continues to be accurate and timely—without unwarranted delay—unless there is complexity.

Mark Simmonds: I confirm that the Minister certainly did not give the impression of complacency on this particular occasion. On that note, I am happy to beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 19 ordered to stand part of the Bill.

Clause 20

Power to suspend licence

Mark Simmonds: I beg to move amendment No. 146, in clause 20, page 15, line 38, at end insert—
‘(2A) No more than four consecutive suspensions under subsection (1) can be granted, totalling a maximum period of twelve months.’.
The amendment relates to the number of consecutive suspensions that the HFEA may allow. Of course it is right that the HFEA should have the power to suspend a licence quickly and efficiently if it has reasonable grounds to believe that the terms of the licence might be broken. It also has the power to renew such a suspension indefinitely.
The amendment will either place an upper restriction on the number of times that a suspension may be renewed to a period of up to one year or establish why that is not acceptable to the Government. Clearly, a suspension for even a short period could be damaging to a business or research project that had a licence up to that point. In my view, it is correct that a decision should be made within a year. By then, the appeal process should have been gone through, if appropriate, and the authority should have had sufficient time in which to investigate, clarify its concerns and rectify any problems.
I would like to make an additional point if I may, Mr. Gale, about the timing of the appeal procedure. How quick will it be? Will it be dealt with within the three-month period, or is that one of the main reasons why there is no limit on the number of times that a suspension may be renewed? Clearly, if appeals can be heard and clarified expeditiously, that will benefit the authority and those who previously had a fully operational, licensed business or research facility.

Dawn Primarolo: Proposed new section 19C retains the right of the authority to suspend a licence, where it considers there are grounds to do so, for a period of three months and for further periods of three months after that, if it sees fit. In my view and in the experience of the authority, given the work that it has undertaken, that is the correct way to proceed and there should be no specification of the number of times that a suspension period has been repeated.
The hon. Member for Boston and Skegness touched on a case from June 2007 in which the HFEA used its powers to suspend a licence for three months, and then suspended it for another three months while it considered an updated report. He will be aware that there was interaction with the High Court in that case and a judicial review of the decision. I am sure he accepts that it is quite difficult to have a maximum period in such circumstances, because the suspension is needed until a decision is taken and there might be external factors to consider, such as judicial appeal or a High Court judgment.
Where we are is right. The period should be three months, with an option to suspend again. Clearly, we expect things to be speeded up—part of the flexibility given in the appeals procedure and the structure of the licensing committee is to ensure that matters are dealt with in that period. That will further reduce the time involved. However, to pick an exceptional case and then argue for a limit given those exceptional circumstances is incorrect. I hope the hon. Gentleman accepts that.
The hon. Gentleman then asked about the period for the appeal. The new provisions permit an appeal to be made within 14 days. Within the new framework for appeals, that will be set out in regulations. Safeguards remain in place to ensure that the suspension continues pending resolution of the appeal in order to protect public safety. It is right that we do not have a maximum period because of other interactions. It is right that we give the HFEA, as we have elsewhere in the Bill, the opportunity to speed up those considerations wherever possible. However, it would be unwise of us, with sometimes complex cases, to set a maximum period when the right resolution could not be achieved. We are talking about patient safety and quality of care. I hope that the hon. Gentleman accepts my comments.

Mark Simmonds: I thank the Minister for that response. I accept her arguments, particularly on judicial review and the time that those often complex cases take. I also take her reassurance on a focus on speeding up the decisions and considerations wherever possible. It is right that safety and quality of provision have to be fundamental to everything that happens under the Bill.
Following that explanation from the Minister, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Mark Simmonds: I beg to move amendment No. 147, in clause 20, page 16, line 4, at end insert—
‘(6) During a period of suspension all necessary, suitable and appropriate steps must be taken by the Authority to ensure there is no damage to the cells, embryos and gametes that were the responsibility of the licence holder or person responsible when the licence was suspended.’.
The amendment relates to the authority having the power to suspend a licence quickly and efficiently in cases where there are reasonable grounds for the terms of a licence perhaps having been broken. Obviously, for the authority to have that right is correct. However, is it right that during the suspension the people undergoing treatment at that centre could suffer or, worse, lose their embryos or gametes?
I am not sure from either the 1990 Act or the Bill whether there is a duty on the authority to ensure that clients are unaffected during a licence suspension and can continue treatment at other licensed premises. Therefore, there is a crossover in how that impacts on the confidentiality of information going between the two.
Also, what happens to the gametes and embryos stored in a facility that is ultimately closed or has its licence removed? Are they transferred automatically to another facility under the auspices and guidance of the HFEA, or are they just allowed to wither, so to speak?

Dawn Primarolo: I assure the hon. Gentleman that the HFEA, within its requirements when it suspends a licence, has to issue special directions. Those special directions allow for the continued storage of gametes and embryos at the clinic. The HFEA would also expect the clinic to make appropriate arrangements for the continued treatment of its patients if a licence were revoked. Furthermore, it would expect gametes and embryos to be moved to another licensed clinic.
As with suspension, the HFEA would also expect the clinic to make appropriate arrangements for the continued treatment of its patients. The HFEA already has the power to do that, so I do not think it necessary to give it further powers under the Bill.
The hon. Gentleman has raised a series of important questions, but I hope that in each of those circumstances continued treatment of patients, safe storage and/or transfer of gametes and embryos will all be dealt with under the special directions, which are part of the licensing requirements.

Mark Simmonds: I am grateful to the Minister for clarifying the safety and continuing existence of those gametes and embryos that have been put in storage in these particular licence facilities, were one to have a licence revoked or suspended. On that basis, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 20 ordered to stand part of the Bill.

Clause 21

Reconsideration and appeals

Mark Simmonds: I beg to move amendment No. 148, in clause 21, page 17, line 2, leave out from ‘wholly’ to ‘and’ in line 3 and insert
‘of persons who were not members of the initial grant, revocation or variation committee.’.
I hope the Minister will confirm that the amendment is not necessary, and that what it proposes already happens in practice. Clearly, however, it is important that those who were involved in an original decision are not also involved in the appeals process. It is certainly important that the appeals process is not only seen to be fair and independent, but is fair and independent, and that there are therefore no prejudices that might have been instilled through the original process.
We have discussed this before. There are, however, concerns surrounding conflict of interest on the licensing committee, and having an entirely new appeals committee mandated in the Bill would prevent such an incidence occurring, and in particular prevent it from occurring again.

Dawn Primarolo: The clause provides for regulations to ensure that membership of the appeals committee is made up wholly or partly of persons who are members of the authority. Regulations relating to the appeals process will be forthcoming to deal with consideration under the affirmative procedure, and they will come into force at the time of the commencement of the relevant provisions in the Bill. In conjunction with the HFEA, we are considering the details of those regulations, which will be the subject of public consultation prior to consideration by both Houses. The issue that the hon. Gentleman raises with regard to appeals committees, who sits on those committees, and their connection or otherwise to the original decision, will be addressed at that point. I therefore hope he does not feel the need to press the amendment to a vote.

Mark Simmonds: I am pleased that the Minister has confirmed that the matter will be addressed in regulations. It is clearly a very important part of the appeal process, and there has to be confidence that this is a fair process among those applying for licences or appealing against the revocation or variation of licences, which is not driven by themselves. Regarding future consultation, the Government had an enormous amount of time to consult before the Bill was introduced in Parliament, and in many cases they did so extremely thoroughly, and with extreme diligence. Why has consultation about this particular part of the Bill not taken place?

Dawn Primarolo: To remind the hon. Gentleman, the 1990 Act prevents anyone who took part in proceedings resulting in the appeal from taking part in the appeal. That is already the case. By ensuring that the appeal is heard by different people, it reduces the potential bias and makes certain that the process is impartial. Under the 1990 Act, members of the appeals committee would not have heard the initial proceedings, although they would all be members of the authority. The new power will enable the committee to be comprised, wholly or partially, of non-authority members, thus allowing for further improvements in the impartiality of the appeals committee. For those reasons, and because of the difficulty of getting the balance that we need, careful consideration is required. With respect, if we were presumptuous and consulted on draft regulations, even though the House had not agreed we had the power to do that before the Bill received Royal Assent, that could cause confusion and difficulty. It is partly about process, but also about the difficult and complex issues that we need to take in a steady fashion.

Mark Simmonds: I am grateful for that clarification and explanation, and I understand the Minister’s points about consulting on draft regulations before the Bill has completed its passage through Parliament, but she will also be aware of the concerns expressed earlier by the hon. Member for Oxford, West and Abingdon and me that draft regulations are rarely amended in that sense when they come before Parliament. However, I accept that they will have to be debated under the affirmative procedure.

Dawn Primarolo: I assure the hon. Gentleman that they will be thoroughly consulted on in draft form. It is such an important issue that I would hope that we would reach consensus before Parliament has its final approach under the affirmative procedure in both Houses.

Mark Simmonds: I am grateful for that intervention. Of course, we all hope that consensus can be reached on such important issues, but the Minister will certainly be aware from the passage of the Bill that consensus on such complex issues is sometimes difficult to achieve. None the less, I listened to what she said. I am pleased that the matter will be clarified in future regulations and will undergo detailed consultation. I hope that when the regulations come before Parliament under the affirmative procedure, the issues will be addressed specifically. On that basis, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Mark Simmonds: I beg to move amendment No. 149, in clause 21, page 17, line 32, at end insert
‘within 28 days of the appeals committee meeting.’.
Again, the issue is the time scale. It concerns the appeals committee and the appeals procedure. Any case that reaches the appeals committee is likely to be lengthy and indeed costly, so it is right that the appeals committee should give its judgment as swiftly as possible to resolve the case either way, prevent undue delay and produce clarity. I do not stipulate that 28 days is the correct figure—it may well be longer than that—but I want to put on record the concern that the appeals procedure could take too long. Will the Minister inform the Committee how long appeals committees take from start to finish? What gap exists between the time when it is clear that somebody wants to appeal and the time when the process starts in detail?
Will the Minister also confirm whether the regulations could be changed so that during the appeals committee, the appellant and the HFEA can give both oral and written evidence, and that that evidence can be made public so that people can see exactly what the process is in a transparent and effective way? Why will written and oral evidence be given and made public only at the initial licensing committee stage and not at the appeals stage?

Dawn Primarolo: On the question of time limits, the limit of 28 days, from the meeting and the point of the hon. Gentleman’s amendment, is a reasonable period, to be perfectly honest, within which an appellant should be informed of a decision. However, we understand that in practice, it is likely to occur much sooner than that. Of the two recent appeals, one took seven days and one took 18 days.
Although I appreciate that the amendment would guarantee that the decision was communicated within a specific time frame, given that practice is already better than that, it is not an issue that needs to be put into primary legislation. In the two cases concerned, when a decision was reached, I am informed that the appellant was informed within 18 days. In the appeals process, the whole decision is considered, and the decision is challengeable. That means that the appeals committee would have to be provided with the same information, and it is on that basis that it needs to look at the information in a particular form. If the hon. Gentleman is not satisfied with that answer—

Dawn Primarolo: May I finish my sentence? I am certainly prepared to go back and clarify with the HFEA the point that the hon. Member for Boston and Skegness is making.

Evan Harris: I am sorry to interrupt the Minister, but it is difficult to catch her attention, and I wanted her to finish her remarks. Are the regulations under this section, and proposed new sections 20A and B, under the affirmative or negative procedure? I did not think that they were listed under the affirmative list on page 34 of the Bill, or relevant page of the Act as it will be amended, although I may have missed something, and I apologise if I have done so.

Dawn Primarolo: I am happy to confirm for the hon. Gentleman that they are the regulations would fall under the affirmative procedure, and that they would be produced in draft for consultation. I said in response to a previous amendment that, although there is not always consensus on some of the issues in the Bill, I hope to ensure, as the consultation would, that before the draft regulations came to the House and the other place for consideration under the affirmative procedure, there was a great deal of agreement about their provisions.

Mark Simmonds: Again, I thank the Minister for her response. I had been led to believe that they were affirmative resolutions.

Evan Harris: I missed a little bit of the debate in which the timing was discussed, but neither page 34 of the Bill, nor the Act as it will be amended, includes the new section. Although I do not doubt the Minister’s intention—it is right that the affirmative procedure should be used—perhaps I have not quite understood where affirmative regulations are listed.

Mark Simmonds: I am grateful for that intervention, but when the hon. Gentleman momentarily left the Committee Room, the Minister confirmed that the regulations would be introduced on an affirmative basis, as she has just done again in response to the hon. Gentleman’s intervention. I am prepared to take the Minister’s word for it.

Dawn Primarolo: Let me put it this way: if there was any doubt that they were not affirmative, they are affirmative now, because I said so.

Mark Simmonds: I am grateful to the Minister for that intervention, and for the reassurance that she will seek further clarity from the HFEA. I would be interested in the response that she receives. On that basis, I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 21 ordered to stand part of the Bill.

Clause 22 ordered to stand part of the Bill.

Clause 24

Register of Information

Mark Simmonds: I beg to move amendment No. 6, in clause 24, page 20, line 10, at end insert—
‘(5) A relevant individual can also be an individual who has reached the age of 18 whose genetic parent was a relevant individual under subsection (4) but did not themselves consult the register and is themselves deceased.’.
There are many circumstances in which a child of a donor-conceived person would like to know their genetic background, and it is now widely accepted that knowing that background is beneficial. A person’s sense of identity is tied up with where they came from, and an increasing number of diseases and illnesses are found to have some basis in our genes, so knowing one’s genetic background is beneficial.
Some people choose not to consult the register, and we should all respect their decision. We would not allow anyone to consult the register if a living donor-conceived person has themselves chosen not to. However, in a specific case where a donor-conceived person has died, their children might like to know their genetic background. The amendment would allow for that person to consult the register only in the case where the donor-conceived person has died.
In the other place, the matter was discussed extensively and the Minister in the other place promised to consider that particular issue further. That is why I tabled the amendment—to try to understand where the Government have got to in their thought process with regard to that point. I accept that it is a complex issue, and indeed I see why the Government, after due consideration of the reading of the Bill in the other place, have decided not to make an appropriate amendment in this area.

Evan Harris: I want to raise questions about some of the assertions made in respect of this matter. While I do not oppose the provision of information to people who are interested where that information is held, and it is quite clear in advance that the donor understands that information might be made available, one has to consider the privacy of parents and individuals who do not want their children—that relates to the point raised by the amendment—or people more generally to know that they were donor-conceived.
It is important to identify the key points. My understanding is that it is clearly of benefit to know whether there is a genetic issue in terms of health, that the Bill already provides for that, and that we are talking in these provisions about identifying information generally speaking. The amendment at least is about getting more information and identifying information. Obviously, it is important that people understand that they are not seeking to marry or enter a sexual relationship with someone who is related to them.
One has to be careful, however, before one asserts for sure that there is significant benefit from knowing one’s genetic background, because there may a disbenefit from discovering a family secret: for example, that there was infertility and donor insemination, that that had been kept secret from the person concerned, or that there may have been infidelity involved. It is not clear to me from looking at what little evidence there is in this area that it has been established that someone will always benefit from being able to know their genetic identity and to establish their genetic background; or, for that matter, that people have an absolute right, or even a very strong arguable right, to have that information.

Mark Simmonds: The hon. Gentleman is right to make those points, and that is why it is important that the amendment can apply only to those whose parent is deceased. I think that that makes a significant difference, certainly with some of the “family secrets” that the hon. Gentleman seems to be mentioning. I think that they start to dissipate once the person involved has died.

Evan Harris: I do not want to get too heavily involved in the generational issue here, because the provisions are prospective, but one can envisage a situation whereby the grandparents of the person seeking the information did not want it known in their family that infertility services had been used. I think that the provision will have to be prospective since a couple of years ago, so we are talking a number of decades hence, but the amendment would provide that those people do not have any opportunity to prevent not just the child who was conceived from finding out—as is the right under the Bill, regardless of whether I think it is a strong right or always beneficial—but a third party, and it is a third party from their point of view. I will be interested to hear the Minister’s response to the amendment. I understand the basis upon which the hon. Gentleman has tabled amendment. One can imagine that it would be of real interest and significance to an individual. That was said in the House of Lords and I do not dispute the sincerity of people who believe that, but I think that what is left out of these debates all the time, especially in the House of Lords, is the right of the people who were patients receiving fertility treatment to have some privacy.
I am a great believer in people who are having fertility treatment telling their children, at an appropriate age, that they were conceived through donor insemination, but it is not my view that they must do that and it is clearly not the Government’s view, because the Government are not forcing them to do so or automatically releasing information.
I think that the Government are absolutely right, because family dynamics are complex and it is not right for the state to wade in in that way. While the amendment is relatively modest in that respect, here and in other debates I urge consideration for the privacy and memory of the parents and patients. If they have not told someone, the fact of it being found out means that they have, essentially, concealed it. That has implications for all sorts of things, including people being written in and out of wills regardless of their legal entitlement to inherit. A can of worms exists here, and I think that that is why we must have caution in all these areas.

Dawn Primarolo: I agree with the points that the hon. Gentleman has just made. I will answer specifically the questions I was asked by the hon. Member for Boston and Skegness regarding the Government’s position. The Bill allows for donor-conceived people, on reaching the age of 16, to contact the HFEA to find out non-identifying information about their donor. This information is, rightly, accessible to donor-conceived people, and has a direct impact on them.
The purpose of allowing donor-conceived people access to information about their donor is to fill a gap in the knowledge that they have about themselves. Many donor-conceived people feel they are missing important information about who they are and where they came from, because one set of genetic information is missing. Information, including identifying information about the donor, is intended to help to address that, and it is for those reasons that provisions are made to allow such people to find out about their donor. Donors sign up to donate on the understanding that such information will be available.
The intention behind the amendment is to shift down a further generation, to allow children of donor-conceived people to contact the HFEA to obtain information from the register regarding their parent’s donor, in a situation where the parent has died and did not make contact with the HFEA. The amendment would allow the child of a donor-conceived person to find out whether they are related to someone with whom they are having, or intend to have, an intimate relationship. In effect, it means giving a child access to details of their parent’s donor conception that the parent had chosen not to access. We can envisage that a parent may well have decided quite intentionally not to access that information, and may have regarded it as personal and highly sensitive. It also raises the question of situations in which the donor-conceived person is not dead but is incapacitated. What do we do then? Should their children be able to go to the HFEA?
The Government said that they would give the issue very careful consideration since it was raised in another place. We remain of the view, having looked again and considered the issues, that access to the HFEA’s register should continue to focus on those directly affected, and that it should be up to the donor-conceived person to decide whether to access the information available to them and who they subsequently choose to pass that information to—including their own offspring.
While we realise that there may be compelling circumstances, it would be difficult to limit access to that specific situation, and wider access to the register would raise broader issues around access to sensitive and personal information. I am also of the view that, on donating, a donor is able to prepare for possible contact from a donor-conceived child, and to envisage the time span in which that may occur. I do not think that it is reasonable for the donor to be much older and unable to expect at what point in time a possible contact might be made.
Although I understand the point made by the hon. Member for Boston and Skegness, we must allow a donor-conceived individual to decide to whom they pass on information if they have accessed it. No one else should have the right to access that information. I hope that that clarifies the Government’s view for the hon. Gentleman. We consider this to be fundamental in terms of the rights of the individuals concerned and I hope that he will not press the amendment.

Evan Harris: I rise briefly to say that I wholly endorse what the Minister has said, the reasons that she has given and the thinking behind it. The Government were right to say that they would reflect on this as it was raised with a great deal of support in the House of Lords. However, as I said, I do not think that the other place considered some of the points that the Minister has just mentioned. It was quite reasonable for the hon. Member for Boston and Skegness to raise the issue, but the Minister’s comments apply not just to this amendment, but to the whole area. I hope that we will have a chance this afternoon, albeit briefly, to discuss the implication of what she has just said for some of the other arrangements.

Mark Simmonds: I thank the Minister for her response. Sometimes if one moves probing amendments in Committee, one tends to agree more with the response rather than the initial amendment. At least the Minister has kindly put on the record that detailed consideration of the debate took place in the House of Lords, and she comprehensively set out the reasons for the decision that the Department, and she as the relevant Minister, have made in not changing the Bill. On that note, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Amendment made: No. 44, in clause 24, page 23, line 7, leave out ‘any of’.—[Dawn Primarolo.]

Mark Simmonds: I beg to move amendment No. 36, in clause 24, page 23, line 42, at end insert—
‘(10) In this section “reasonable period” means a period of no longer than 3 months’.
The amendment relates to the definition of “reasonable period”. In this section there does not seem to be any definition of what is deemed to be a reasonable period, despite the phrase being used in subsections (6)(b) and (7)(b). I would be grateful if the Minister could clarify her perception of a reasonable period, and whether it will be specified and set down in regulations or whether it will be interpreted as and when appropriate by the HFEA.

Dawn Primarolo: We believe it right that if donors wish to ask for specified non-identifying information about the child, they should be able to do so. That right should be made clear in the Act. The clause sets out two possible routes for finding out that information. Information about the number, sex and year of birth of children born from donations is held on the HFEA’s register.
Where donors have donated through a licensed clinic or regulated sperm donation service, the most obvious route for their inquiry will be through that clinic or regulated service. Subsections (6) and (7) provide that the HFEA need not comply with the request from a donor if the clinic or regulated sperm donation service where the donor donated is still operating. That is unless the donor has asked for the information first and the clinic has failed to respond within a reasonable time period, or if it has notified the donor that the information is not held. In such cases, the donor can seek the information from the HFEA, which must comply if it has the information.
The amendment would specify a reasonable time period, which would not exceed three months. If the clinic had not provided the information to the donor within the specified time period, the donor would be able to go straight to the HFEA. I recognise that three months might be considered a reasonable period in which to receive the information, but to specify it in the Bill would be over-prescriptive and bureaucratic, and would not allow the HFEA to determine the policy in the flexible manner that we have set out. I am sure that the hon. Member for Boston and Skegness can understand that it might not always be able to comply with three months, given the access points, the types of information that might be held and the different places that donors might have to go to. We would expect that to be done without unnecessary delay, but I would ask him not to press for a three-month limit to be put in the Bill.

Mark Simmonds: I thank the Minister for that clarification. I tabled the amendment to ensure that she and the HFEA understood the importance of the speed of provision of information and of putting pressure on clinics to provide it as quickly as possible. However, of course I understand her sensible points about being over-prescriptive in the Bill and thereby reducing flexibility. I very much hope that the HFEA will take on board comments made and perhaps even set out in guidelines an initial time scale for providing such information wherever possible. On that basis, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Stephen McCabe: I am advised that we will probably not be able to complete the clause stand part debate in the time that some of us might have hoped. Consequently, I beg to move that further consideration of the Bill be now adjourned.

Roger Gale: Let me make the position plain. These are extremely complex issues and require a very high level of concentration, if we are to do them justice. I speak for nobody other than myself in saying that I find this quite difficult to follow, and the Chair needs to follow it very carefully. I believe that three hours in one sitting is long enough. I am perfectly happy to suspend the sitting and come back, but it seems that we have covered a great deal of ground today. I think that a period of reflection might refresh us all and allow hon. Members to have a good stand part debate on Tuesday morning.
Further consideration adjourned.—[Steve McCabe.]

Adjourned accordingly at two minutes past Four o’clock till Tuesday 10 June at half-past Ten o’clock.